The Hill, a Washington-based news publication, recently published a story about the New Swine Slaughter Inspection System (NSIS), an outgrowth of the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) HACCP-Based Inspection Model Project (HIMP) with these warnings: “A new rule . . . would reduce the number of government food safety inspectors in pork plants by 40 percent and remove most of the remaining inspectors. In their place, a smaller number of company employees — who are not required to receive any training — would conduct the ‘sorting’ tasks. The rule would allow companies to design their microbiological testing programs to measure food safety rather than requiring companies to meet the same standard.”

The story continued “. . . the new rule would remove all line speed limits in the plants, allowing companies to speed up their lines with abandon. With fewer government inspectors on the slaughter lines, there would be fewer trained workers watching out for consumer safety.”

The limitations were obvious. Poke-and-sniff could find quality control problems, such as carcass bruising and broken bones. But E. coli O157:H7 contamination or any of the other pathogenic bacteria that might be present takes a swab and a petri dish.

The USDA believed checking for bruising and other visual imperfections can be done quickly and efficiently online by people with reasonably good eyesight. Better to sample and test for contamination in the lab than try to watch for it at even 10 carcasses per minute. Their research was designed to bring food safety practices from its mid-20th century roots to the 21st century, a nearly 60-year leap forward. 

Still, the FSIS plan met with considerable controversy. To learn the facts as FSIS saw them, I called on Mindy Brashears. She was a professor of food science at Texas Tech University until she was nominated by President Trump to lead the FSIS. 

Coming on to the scene after almost all the work on HIMP was complete, she had no real skin in the game. She took a fresh look at it, more than ready to veto the program if it didn’t meet some very rigorous scientific standards. I asked her some questions about the program and her reactions to it.

Q. The new swine slaughter inspection system (NSIS) has been piloted at five pork processing plants and was developed over many years of research and evaluation. Would you walk me through that process? 

A. Because NSIS was on the horizon when I began with FSIS, I took a special interest in reviewing the proposed rule with an intense focus on the history and data collected to inform the rule. I took a very scientific approach to analyzing the system as I have done with other major tasks in my career. I asked for all of the data collected (not just summary data) and also conducted a thorough review of methodologies, study design, peer reviews and statistical analysis (among other things).

My commitment at FSIS is to make data-driven, science-based decisions and I had to be confident that this new system was the right thing to do. After weeks of reviewing data, visiting plants and having in-depth conversations with our staff, inspectors and even employees at establishments that operated under the new system, I was confident that the move to NSIS was the right thing to do to protect public health and improve food safety.

What is also very important to note is the fact that I also listened to opposing arguments against moving ahead with NSIS.  Regardless of the individual or group making a claim or request, I have a high standard for data and science.  We can’t make decisions based on emotion, hearsay or anecdotes because lives are at stake. Not one single opposing group was able to provide any genuine data to indicate we should not move forward with NSIS on any point of contention related to public health. It is important that the facts are the facts so we can make our food supply safe and move forward to protect the American citizen from foodborne illness.

I’m happy to walk you through our scientific approach to modernizing swine inspection on a high level because there is a large amount of information and data that went into making this deliberative and thoughtful decision. The research did not begin overnight and actually stretches back to the late 1990s after the transition to Hazard Analysis & Critical Control Points (HACCP)-based systems in meat and poultry processing plants. As you already know, FSIS adjusted the overall processes and sanitation in federal establishments to focus on pathogen prevention by implementing HACCP/Pathogen Reduction (PR) regulations and Sanitation Standard Operating Procedures (SSOP).

In 1997, FSIS initiated the HACCP-Based Inspection Models Project (HIMP) pilot in 30 volunteer slaughter establishments (20 young chicken, five turkey, and five market hog) to determine whether new slaughter inspection procedures, along with new plant responsibilities could improve food safety—while simultaneously increasing consumer protection. These facilities have been successfully operating under this system for more than 20 years and data collected in these facilities has informed decisions for New Swine Inspection Systems (NSIS) and New Poultry Inspection Systems (Implemented a few years ago).

The five comparable market hog slaughter establishments listed below volunteered for the HIMP pilot:

• Clemens Food Group, LLC in Hatfield, Pa.
• Quality Pork Processors in Austin, Minn.
• Smithfield Packaged Meats in Vernon, Calif.
• Swift Pork Company in Beardstown, Ill.
• WholeStone Farms Cooperative, Inc. in Fremont, Neb.

More than 20 years later and with significant experience and data in hand, FSIS issued the Modernization of Swine Slaughter Inspection proposed rule in 2018. This rule was formed by pathogen data collected in the facilities as well as data collected on inspection tasks.  Summaries of the data are in the presentation. Most people do not know that the Agency prioritizes inspection tasks that are directly related to pathogen presence and public health. As you would expect, inspection tasks related to HACCP and Sanitation rank high when it comes to food safety.

In the HIMP systems, the inspection tasks directly related to food safety and public health were increased. The agency also initiated a full risk assessment, including a response to peer review comments, that can be reviewed on the FSIS website. The bottom line of the risk assessment was that more than 2500 Salmonella illnesses each year would be prevented when moving to the modernized system.

The final rule was published in September 2019 and has two parts:

• All official swine slaughter establishments are required to develop, implement and maintain in their HACCP systems written procedures to prevent the contamination of carcasses and parts by enteric pathogens, fecal material, ingesta and milk throughout the entire slaughter and dressing operation. These procedures will include sampling and analysis for microbial organisms to monitor process control for enteric pathogens, as well as written procedures to prevent visible fecal material, ingesta and milk contamination.

An important aspect of this that never gets mentioned in the media is the fact that now the establishments must test for indicator bacteria in two locations for process control to determine if the process is preventing contamination. These requirements are for all swine facilities.

• The New Swine Slaughter Inspection System (NSIS) which establishments can choose to operate under or they can remain under the traditional slaughter inspection system. NSIS does NOT delegate any inspection authority to the plant. FSIS inspectors perform all inspection tasks and there is still 100% ante-mortem and post-mortem inspection.

There is a reduction in the total number of inspectors. Those under NSIS will not have food inspectors present in the plant. They will have Consumer Safety Inspectors (CSI) and our DVM inspectors.  The CSIs have more experience and training in food safety, HACCP and Sanitation tasks and will be performing the online and off-line inspection tasks.

Establishments choosing to operate under the new system are required to sort and remove unfit animals before FSIS ante-mortem inspection and to trim and identify defects on carcasses and parts before FSIS post-mortem inspection. In a traditional inspection system, the inspector would see a defect (bruise, fecal contamination, etc.) and then direct the plant employee to remove it.

Now the plant employees are allowed to do that before it reaches the inspector, so the carcasses are cleaner when inspection occurs. If a defect is found by an inspector, then the plant must still go back and take corrective actions. As already stated, FSIS is still conducting 100% carcass-by-carcass inspection as required by law but now the plants are responsible for only presenting product that will pass inspection. This allows FSIS inspectors to focus more on food safety issues and less on quality defects.

Again, and I can’t emphasize this enough, USDA inspectors will continue to conduct inspection of all animals at ante-mortem and all carcasses and parts on post-mortem as mandated by Congress.

Q. What input did you get from industry resources like the National Pork Board and the National Pork Producers Council? How about the general public?

A. The proposed rule received over 83,000 public comments, which were reviewed and addressed in the final rule. The agency received overwhelming positive support from industry groups like the National Pork Board and the National Pork Producers Council due to FSIS’ desire to bring innovation to the inspection process, while still producing safe and wholesome pork products for consumers.

It is important to remember that five companies were already operating under this system for more than 20 years so the industry was very familiar with the successes and benefits of this program. In some regards this is also about leveling the playing field so that all of industry can operate in this inspection system and innovate like their five counterparts above.

Other comments received from the general public may be read, along with the agency’s response, in the final rule.  Each and every comment was considered and a response was given categorically.

Q. NSIS is an outgrowth of the HIMP program, of course, which dates back to 1997. Will its adoption lead to similar programs – sooner or later? And will it take 20+ years to test and begin to implement?

A. The agency has a mission to ensure that everyone’s meat, poultry and processed egg products are safe. Government inspection must keep pace with the scientific world. It is our obligation to the consumer to allow for the implementation of innovative solutions and new technologies as well as systems that protect public health. It is a challenge because generally people do not like change and are opposed to innovation. Think about all of the safety and scientific advances over the last 30 years such as airbags, smartphones and here we are doing inspection the same way we were 50-60 years ago.

Unfortunately, many groups want us to stay stuck in the past. We will not. We are committed to improving food safety. This means that the modernization of inspection and policies is necessary in order to protect public health. As a scientist, I’ve seen pathogens constantly adapt to their environment, so we must continually modernize our approach to stay ahead of their impact on our food supply.

For poultry, FSIS published a final rule for the New Poultry Inspection System (NPIS) on Aug. 24, 2014, which serves as an optional inspection system for young chicken and all turkey slaughter establishments. NPIS also reduces the risk of foodborne illness by focusing FSIS inspection activities on those tasks that reduce contamination on chicken and turkey products. As of Dec. 17, 2019, there are 126 USDA poultry slaughter establishments operating under NPIS and it has been a successful transition. It is important to note a trend towards improved food safety because, after a year of collecting data, 89% of the plants under NSIS are meeting performance standards for Salmonella. We will continue to monitor this.

Under NPIS, one federal inspector is assigned to each evisceration line to conduct postmortem inspection of each carcass and one off-line inspector for each evisceration line to conduct food safety and other verification inspection tasks. 

FSIS recently conducted an analysis to determine whether specific off-line inspection tasks were performed more frequently after an establishment’s conversion to NPIS. The analysis includes 72 formerly non-HIMP establishments that converted to NPIS, using Public Health Information System (PHIS) inspection task data from May 2015 to April 2019.

The analysis illustrates that:

• Inspectors consistently completed a higher number of selected food safety-related offline inspection tasks, including the new NPIS inspection tasks after NPIS implementation.
• The new NPIS Zero Tolerance Food Safety Verification task is being performed at or near four times more often after NPIS conversion as compared to the pre-NPIS Poultry Zero Tolerance Verification task.
• The rate of noncompliance records (NRs) documented for these zero tolerance verification tasks more than tripled in conjunction with the increase in tasks performed.

This indicates that NPIS is working as intended and continues to ensure food safety. Please click here to read the final rule, risk assessments, status on the number of poultry plants that have converted to the NPIS, and the recent analysis.

FSIS leadership and I have been very public about our intentions to modernize all components of inspection. The agency mentioned beef modernization at numerous food safety and stakeholder conferences and even held two roundtables in May of 2018 to gather feedback and ideas on how the agency could modernize its approach to inspecting beef. It is FSIS’s statutory duty to protect public health by ensuring we modernize our inspection systems, policies and use scientific approaches and we will be committed to overseeing beef modernization. Initially, this will be done on a case-by-case basis using a waiver system. Those operating under the waiver will be assessed and data collected will be used to inform the future of beef modernization.

In 2020 we also plan to announce modernization of egg products inspection. For egg products, we will move to a HACCP-based system as we have already done in meat and poultry operations.

Q. The plan was endorsed by the National Association of Federal Veterinarians, a strong note of approval from a very well-respected organization. Several other groups strongly object, citing the end of online inspection, faster line speeds, and the ability of a plant to ‘set its own rules’ as dangerous and detrimental to food safety. How do you respond to their fears?  

A. Let me be clear: FSIS has not delegated any of its authority. There is much misinformation out there. Online inspection has not ended at all.

There are key differences between NSIS and traditional inspection:

• Under traditional inspection, market hog establishments voluntarily segregate animals before FSIS inspection. Under NSIS, this sorting process will be mandatory.
• Under NSIS, if establishment employees do not properly sort animals for food safety conditions before FSIS inspection, the establishment will receive a non-compliance record (NR). They do not receive NRs under traditional inspection.  This is a motivation factor for plants to do things correctly.

As already stated, under the final rule, FSIS inspectors will continue to conduct 100 percent carcass-by-carcass inspection; the plant employees will prepare and present the carcasses and parts to FSIS inspectors for inspection. Also, FSIS inspectors will continue to slow and stop the line to ensure food safety and inspection are achieved. The inspector always has the right to do this even when the plant is operating at increased line speeds.

In the HIMP studies, there was little difference in line speeds.  It is not as if the lines will be running out of control (see the presentation for details).  A couple of practical things I want to point out:

1. The plant will still be bound by cooler space and the number of carcasses that can be put in a cooler.

2. Line speeds are ONLY in slaughter areas because they are set for inspection.

If needed, our inspectors can slow the line. There has never been a line speed limit in fabrication or other downstream processing areas. The most important thing to note about line speeds is the fact that you can stop the line and observe an entire carcass, and you will never see Salmonella, Campylobacter or any other pathogen. We must focus on HACCP, sanitation and implementation of food safety technologies to keep the product safe. Our modernized inspection systems are the next phase of HACCP implementation as we focus inspection resources on off-line tasks related directly to food safety.

The final rule also allows FSIS inspectors to complete more offline food safety and humane handling verification tasks to monitor compliance. These offline inspection tasks have a more direct impact on food safety and animal welfare.

I hear all of the fears cited by these special interest groups, but as a scientist, I can’t rely on anecdotes. I tell all of these critics and groups “bring me the data” and yet none of them can. At the end of the day, I can only assume this is a basic fear of change or some ulterior motive that is causing them to spread misinformation and fear.

Q. Pork plants have the option of working the new program into their in-plant processes or standing pat with their current program. Won’t trying the blend the old with the new create industry and public confusion?

A. No, the process is very straightforward. The final rule gives market hog establishments the choice to operate under NSIS or to continue to operate under the traditional slaughter inspection system. All market establishments will initially have six months from the date of publication in the Federal Register to notify their district office of their intent to operate under NSIS. Establishments that do not notify their district office of their intent to transition during this time will be deemed to have chosen to continue to operate under traditional inspection. Market hog establishments that decide that they would like to convert to NSIS after the initial notification date may notify their district office of their intent at any time after that date.

FSIS will then implement NSIS in the additional establishments that intend to convert on a schedule consistent with the availability of agency resources and establishment readiness.

As previously noted, some aspects are required for all establishments.

Q. The rollout has just begun. How is it going? Who’s onboard? What are some of the objections and “attaboys” you’ve heard?

A. Some establishments have contacted their FSIS district office expressing interest in converting to NSIS. However, to date, the agency has not received a written commitment with a proposed conversion date from any swine slaughter establishment. The final rule published in the Federal Register on Oct. 1, 2019 and establishments have until April 1, 2020, to notify their FSIS district office of their intent to operate under NSIS. As we begin to roll out the system, I will be happy to follow up with additional information.

Editor’s note: This is an edited and shortened version of Chuck Jolley’s interview with Mindy Brashears that was originally posted by Feedstuffs. It is published here with permission.

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A spokesman said, “The School management team recognizes that experienced food professionals are generally well-versed in their core scientific knowledge, academic education and work experiences. We want to build on their working food industry knowledge to strengthen the critical thinking, decision making and leadership skills that are essential to be an effective food industry professional.”

The ISFP uses Bloom’s taxonomy, a multi-tiered model of classifying thinking according to six cognitive levels of complexity, as the basis for its structured learning approach.

Throughout the years, these levels have often been depicted as a stairway climbing to a higher level of thought. The basic levels are knowledge, comprehension, and application. The highest levels are analysis, synthesis, and evaluation. Bloom’s learning objectives are used to define how well a particular skill or competency is learned or mastered.

To meet the complex food safety challenges facing the food industry, the ISFP curriculum was developed to go well beyond current education and training standards. Introductory courses are designed to allow students to learn the complex interdependencies that characterize the global food supply environment.  That knowledge serves as a building block to move to more advanced levels of learning.

Successive courses introduce students to the higher order thinking skills: analysis, synthesis and evaluation. Upon completion of the courses, students should gain a mastery of critical thinking, decision-making and the essential skills necessary to be an effective leader in the globalized food protection environment.

The ISFP curriculum is influenced by science and technology to reflect the changes taking place in the food industry.  It encourages people to look at old problems in new ways in order to find unique solutions. Courses teach the newest science- and risk-based methods and implementing technologies to help food enterprises increase their competitive advantage across areas including food defense, food safety, asset management and protection, bio-safety, information technology, critical infrastructure protection, business intelligence, risk management and organizational transformation.

The advancement of skill levels at the ISFP is tied to achieving higher “belts,” similar to the martial arts, starting with a White Belt based on knowledge gained working within the food industry. A Yellow Belt is attained by successfully completing two 3.5 day onsite training courses that include eLearning: one in food defense and second in food safety.

Next are the Green, Blue and Red Belts leading to the final mastery of the complete curriculum at the Black Belt level – students who have become Certified Food Protection Professionals (CFPP).

The ISFP faculty, according to a spokesman, brings experience from industry, government, the military and academia to the classroom. Their advanced degrees are supported by real world work experience. They possess the teaching skills which enable them to integrate their subject matter expertise with case studies, experiential exercises, advanced technology tools and the most current thinking and practice in food safety and food defense.

The Dean of the ISFP is Dr. Bart Michelson. He has served as a senior consultant and advisor to the Department of Defense, working with the DOD Senior Executive Leadership Program, Joint Staff, Armed Forces Inauguration Committee, J7 Joint Vision and Transformation Directorate and US Army Strategic Advanced Computing Center. He has provided similar services to other Federal Agencies including the Department of State’s Foreign Service Institute, the Office of Homeland Security, Office of Personnel Management’s Federal Executive Institute, Nuclear Regulatory Agency, National Geospatial Agency, and Department of Energy National Laboratories, as well as numerous business and non-profit organizations.

The corporate sponsor of the ISFP is FoodQuestTQ, LLC, a software technology company, located in Frederick, Maryland, established in 2010 to develop a new generation of quantitative risk management tools for the food industry. FoodQuestTQ will be offering these tools at the National Food Protection Collaboratory beginning July 10, 2012.

The National Food Protection Collaboratory (NFPC) is a web-based, world-wide community of people, businesses and organizations dedicated to the goal of keeping the world’s food supply safe and abundant.  The International School for Food Protection (ISFP) was founded to be the professional development and research component of FoodQuestTQ, LLC.

FSI and FPSA has announced a free 1-hour webinar called “Lean Finely Textured Beef: Separating Myths and Reality,” presented by Dr. Keith Warriner of the University of Guelph. Dr. Warriner is an internationally known and respected researcher and lecturer in the field of food safety, as well as one of FSI’s regular and most popular webinar presenters.

Aaron Brown of FSI said he chose the topic of Lean Fine Textured Beef (“LFTB”) because “it has been featured prominently in the news lately, and it is a topic laced with controversy.”

Most of the ‘news’ has been weak on facts and strong on stampede journalism.  The initial photograph that accompanied the early news stories, for instance, was ‘lean, finely textured poultry,” not beef.  The product descriptions tended to be overwrought and misleading.  Social web sites latched onto the initial and factually incorrect reports and rebroadcast them extensively – going ‘viral’ in a matter of hours.

In the FSI webinar, Dr. Warriner takes a fair and balanced approach, letting the facts tell the story.  His comments will probably be dismissed as the words of an industry lackey by the likes of ABC’s Jim Avila, the product’s leading assassin.  Warriner’s credentials are first-rate, though, and his knowledge is light years ahead of the so-called reporters who added little to the story.

Although it’s too late to save bankrupt LFTB supplier AFA Foods, a near billion dollar company and its 850 jobs, it might help save BPI, the main resource of the product and a company with an outstanding food safety record.  A BPI company spokesman just announced that the shutdown of three of their plants will be permanent, leaving 650 people out of a job, and the reduced production at their main plant will continue.

The lost business was caused in part by several major fast-food restaurant chains that stopped using LFTB to avoid adverse publicity, led by McDonald’s, Burger King and Taco Bell.  The product was also made an ‘option’ for school food service purchases as the USDA bowed to pressure created by a petition drive launched by Bettina Elias Siegel, the Lunch tray lady (www.lunchtray.com).

FSI posted the LFTB 1-Hour presentation on YouTube for ease of access. Click on this link if you’d like to see it. 

“Today, USDA announced an extension to the public comment period for a proposed rule that would modernize the poultry slaughter inspection system,” she wrote. “This new plan would provide us with the opportunity to protect consumers from unsafe food more effectively. We recognize that this proposal would represent a significant change from the current system and has sparked a debate on how poultry is inspected. We also value the different opinions being expressed about the proposal and have extended the public comment period to ensure all sides are presented in this debate.”

The Government Accountability Project (GAP) was one of the first organizations to express serious doubts about the HACCP Inspection Models Program (HIMP) which had been flying comfortably under most watchdog radar, probably overshadowed by the never-ending “pink slime” controversy.  GAP grabbed three USDA inspector whistleblower inspectors and their affidavits expressed these concerns:

– At non-HIMP plants, line speeds for bird inspection are set at 72-90 birds per minute (bpm) with multiple federal inspectors monitoring the line, so that each inspector is in charge of overseeing approximately 30-36 bpm. At HIMP plants, however, this line speed increases to 165-200+ bpm with only one federal inspector monitoring the production line for infected/tainted product. This means that one federal inspector is going to be responsible for safeguarding over 10,000 birds per hour. These rates are so fast, that inspectors simply cannot look at every bird.

– Under HIMP plans, federal inspectors are replaced with plant workers who are powerless to speak out against their employers, and are responsible for removing adulterated product. The inspector whistleblowers have witnessed that these sorters are “rebuked by supervisors” when they try to slow down the line for food safety concerns.

– Under traditional inspection methods, inspectors can see all sides (and the inside) of the bird. But inspectors at HIMP plants can only see the backside of the bird – not the front (where the breast meat is) that may clearly show tumors or scabs. Nor can HIMP inspectors see the inside of the bird, where fecal matter and other disease causing abnormalities are found.

– In each Inspector’s case, the placement of the “Critical Control Point (CCP)” – the main purpose of which is to identify and catch potential food safety problems – under the HIMP plan was moved to a point further down the conveyor line, after a key “Inspection Station.” This has the effect of taking away the inspectors’ ability to see noncompliances or issue Noncompliance Reports (NRs), documentation showing a plant CCP’s failure to prevent important regulatory violations. Multiple NRs can lead to increased enforcement action against the plant.

GAP said each of the three inspectors clearly conveyed in their affidavit that a nationwide implementation of the HIMP plan makes it more likely that unsafe products will reach consumers.

Let me insert a point/counterpoint here. The days of ‘poke-and-sniff’ inspection are thankfully long gone and those on-line inspectors are the last vestige of that practice. You can’t see or smell Campylobacter or Salmonella.  Visual inspection for pathogen detection is a pointless pursuit.

On the other hand, it’s easy for an inspector to spot quality control problems like fecal contamination, bruising and feathers.  But not at 160+ birds per minute, especially when half the bird is not in line-of-sight?  Blink and you’ve missed half a dozen birds.

Dr. Hagen wants federal inspectors “to focus on food safety tasks, such as ensuring sanitation standards are being met and verifying testing and antimicrobial process controls.” She suggests a major shift in their responsibilities.  Let plant employees look for feathers and other visual contamination; the feds should spend their time making sure poultry processing facilities are taking the appropriate steps to control food safety hazards.

Her very valid point: FSIS inspectors would no longer be partly responsible for quality assurance which is a “protect the brand’ effort that properly belongs to the poultry processors; they would become more responsible for food safety, the real reason they’re in the plant, anyway.

The USDA is now trying to make a change suggested by the HIMP pilot program started in 1999. Twenty carefully selected broiler plants served as “trial plants” for this long term test. Results showed lower rates of Salmonella and USDA officials concluded that quality assurance tasks, such as checking for bruises and blemishes, don’t provide adequate food safety protection.

It’s a program that earned the enthusiastic backing of USDA Food Safety and Inspection Service Administrator Al Almanza, who wrote about it on April 13 in the Huffington Post.

He wrote, “If we’re going to have a debate on the merits of this proposal, I welcome it. But we need to use the same facts in this important discussion. It is not an honest debate when some people are saying that line speeds are going from 35 birds per minute (bpm) to 175. That is simply not the case. Right now, under our current regulations, line speeds are capped at 140 bpm. Additionally, the 20 broiler plants under a pilot program started in 1999, known as the HACCP Inspection Models Program (HIMP), are allowed to go up to 175 bpm. In other words, we have more than a decade of experience slaughter running at 175 bpm, the proposed maximum line speed in the rule. And the data is clear that in these plants, the poultry produced has lower rates of Salmonella, a pathogen that sickens more than 1 million people in the U.S. every year. These plants also maintain superior performance on removing the visual and quality defects that don’t make people sick. Those are the facts, based on the data.”

The proposal has earned the unqualified backing of the National Chicken Council and the National Turkey Federation as it should.  It takes the handcuffs off production and saves the poultry industry millions annually.  With those changes, however, come some serious public relations concerns.

The folks who are against the idea will suggest that faster line speeds will create more food safety problems and will be the first to scream “I told you so” when the first recall happens.  It won’t matter that line speed might not be the cause.  

And a recall will happen.  Shortly after the massive 1997 Hudson Beef recall, I attended a National Meat Association conference where Michael Mina, one of Almanza’s predecessors at FSIS said, “There are two kinds of businesses in the meat industry; those that have had a recall and those that will have a recall.”

And I would add to Mina’s wisdom some perfectly tim
ed comments made last week by Food Safety Summit Keynote speaker Oscar Garrison, Division Director, Consumer Protection, Georgia Dept. of Agriculture and President of the Association of Food & Drug Officials (AFDO).  He divided food plants into three groups –

A. Top performers, they know how to do things right and have considerable resources to make sure their products are as safe as possible.  Federal or state inspection rarely finds a problem and probably can’t contribute anything to their efforts.

B. Good performers, they want to do things right but don’t have the access to the skills and technology of an “A” company.  Federal and states agencies can help them with advice on best practices.  Problems are still rare but are more likely to occur.

C. The bad actors (less than 2%, according to Garrison), doing the right thing is not a top priority.  Given a choice, they’ll often make the wrong one.  Close monitoring is a requirement.

Those 20 plants chosen 13 years ago for the USDA pilot program?  Were they all ‘A’ plants or a more statistically correct grouping of A”s, B’s and C’s?  Were they forewarned and forearmed about inspections so that they might ramp up their food safety procedures to insure a good report card?  And about those FSIS inspectors who have been tagged as ‘whistle-blowers?’ Sure, they’re guilty of trying to protect jobs – the new proposal would eliminate 75% of them, saving the government millions in tax dollars – but let’s not let that completely taint their opinion.  They’ve been the front line guys on this food safety battle from the beginning and their concerns must be given a fair hearing.

It’s a good thing that the decision to move forward with the HIMP plan has been delayed while the feds collect more comments. The fallout created by the inevitable recall if the plan is perceived as being pushed through without due diligence would be devastating to the poultry industry.  It would make the recent ‘pink slime’ issue seem like a warm up bout prior to the main event.

PS: Someone remarked that this HIMP-inspired self-inspection was like letting the fox guard the henhouse.  Never was there a more appropriate simile.  Not saying that poultry plants would intentionally game the system, but at the first hint of a problem, public opinion would quickly go there, gleefully spurred on by certain special interest groups.

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Chuck Jolley is president of Jolley & Associates, a marketing and public relations firm that concentrates on the food industry. 

It has two primary benefits: It’s a very low-cost additive and it is as close to an absolutely safe product as humanly possible to produce. Its biggest negative?  Celebrity chef Jamie Oliver started a devil’s chorus of condemnation when he labeled it ‘pink slime’ on the season premiere of his now-cancelled ‘Food Revolution’ TV program. Watch the segment on YouTube: (http://www.youtube.com/watch?v=wshlnRWnf30)

It was the second major victory of ignorance over science. The first being the almost complete beat-down suffered by irradiation a decade ago.

Irradiation’s opponents cried out that the process gave beef processors free rein to take unwarranted shortcuts – not cleaning carcasses, for instance. “Irradiated poop is still poop,” they said, “and this will allow them to sell that crap to the public.”

Of course two facts — (1) irradiation is almost a “silver bullet” that can eradicate most food borne pathogens and (2) it was designed as an end-of-production additional hurdle to be used after several other food safety steps, including thoroughly washing that carcass, had already been taken — were shunned in the stampede away from the process.

“No!” said the Safe Food Luddites. “The American public should not be forced to accept glow-in-the-dark meat liberally dosed with irradiated poop!”

But back to the damage that Oliver created. He demonstrated how “70 percent” of America’s ground beef contains leftover cow parts (aka “pink slime”) containing E. coli and Salmonella that has been treated with ammonia. Seventy percent seems a little high, I’m sure BPI founder Eldon Roth would be delighted with that share of market and I know most food safety advocates would love the results.

And saying those “leftover cow parts” contain E. coli and Salmonella is taking gross liberties with the truth.  OK, let’s call it what it is: A lie written for maximum emotional impact. Even if some very small percentage was contaminated, the food safety practices used by BPI would quickly identify the problem and their process would eradicate any pathogens.

BPI was the first company to hold and test for the “Big Six” E. coli pathogens, for instance, announcing the decision on July 14, 2011, well before the announced FSIS mandated deadline of March 5, 2012. In a press release a company spokesman said, “This first-of-a-kind action is part of the company’s ‘hold and test’ quality assurance program through which BPI samples its lean beef prior to sale, holds the lean beef, and tests for the presence of pathogens. Only after determining the test results are negative will beef be sold or used for raw ground beef.”

Keith Nunes, executive editor of Food Business News, writing for Meat&Poultry magazine, said “due to negative publicity, the company that once promoted the fact its boneless lean beef is used in the hamburgers manufactured for most of the nation’s major fast-food chains has seen some of those customers tell their suppliers to stop using the Beef Products lean beef.  Negative publicity about the company’s process and the use of the compound ammonium hydroxide, a critical component of the process, is at the heart of Beef Products’ recent challenges.” 

Opponents would have you believe that large vats of contaminated beef are drowned in household ammonia at BPI and then masticated into a chemical goo that’s hidden in meat patties that are being force-fed to innocent children in school lunch programs.

Nunes pointed out that the meat is exposed to “ammonium hydroxide, designated as ‘generally recognized as safe’ for use in food by the Food and Drug Administration in 1974 and it has been used as a leavening agent in baked foods as well as a way to manage the pH in many types of food products since then.”

BPI has been upfront about the safety process and the scientific review that went into evaluating its effectiveness as a food safety tool. Its processes and products have received accolades by many people in the food safety arena.  Nancy Donley, the founder of Safe Tables Our Priority (STOP) and one of the most well-known and respected observers of the food industry, praised Eldon Roth and his work at BPI when she helped inaugurate him into the Meat Industry Hall of Fame in November.

Stating some of the science behind the process, Nunes wrote, “Ammonium hydroxide is naturally found in proteins such as beef, pork and chicken. What the Beef Products process does is increase the amount of ammonium hydroxide in the lean beef to elevate its overall pH and make the product inhospitable to the survival of pathogens such as E. coli O157:H7 and Salmonella.”

Nunes was concerned that unfounded public perceptions were being used “to cast a negative light on a process that is proven to be safe and has been designed to protect consumers.” 

“The situation Beef Products finds itself in is not isolated,” he wrote. “Other processes, such as the use of bisphenol A, are also being challenged. Food safety is not a natural, pure or simple process and products will be less safe if effective processes are shunned for reasons that have more to do with perception than science.”*

Making sure our food supply is as safe as possible requires the use of some sophisticated science, and emotional reactions by people who speak before they understand the process will delay acceptance at best.  The worst case, though, is their unwarranted and unsubstantiated fears can stop needed and proven scientific advances cold, exposing thousands of people to easily avoidable illnesses and death.

*Read Keith Nunes’ editorial in MeatPoultry.com magazine

———————

Chuck Jolley is president of Jolley & Associates, a marketing and public relations firm that concentrates on the food industry.

AMI asked for official recognition of low dose, low penetration electron beam (e-beam) irradiation applied to the surface of chilled beef carcasses as a processing aid. It would exempt treated beef from irradiation labeling, a current requirement that the trade association fears would frighten some consumers and limit sales.

For most of that time, the FSIS had been dead silent while the AMI kept up the pressure, asking for a decision on a petition that had more than enough science to support it.  For most of that time, the petition might have been ‘lost’ in some odd file in some labyrinthine building where politically uncomfortable requests are supposed to go to die.

Dr. Richard Raymond, appointed USDA Under Secretary for Food Safety in 2005 and the presiding officer responsible for overseeing the policies and programs of the FSIS during the early days of their non-decision, told me, “AMI sent the petition over to FSIS just before I got sworn in. The very first I even heard about it was from AMI the summer of ’08 after I had announced I was leaving Oct 1. The petition had sat in (Dan) Engeljohn’s office for three years with not one single action being taken. I think he thought he should keep it from me for fear I would want to move forward on it. All I had time to do was put together a conference on Sept 18, 2008, for industry and consumers to be able to at least air and voice their science and their concerns. There is at least a public record of those thoughts now.” 

Regardless of where the petition sat during those years or Dr. Engeljohn’s intentions, here is what he wrote to Dr. Booren:

“This letter is in response to your July 8, 2005 submission, Citizens Petition to Recognize the Use of E-beam on Carcasses as a Processing Aid. In your petition you requested that the Food Safety and Inspection Service (FSIS) officially recognize low dose, low penetration electron beam (e-beam) irradiation applied to the surface of chilled beef carcasses as a processing aid and, thus, such beef would be exempt from labeling. After reviewing the available information associated with this request (refer to attachment 1),

FSIS believes that beef carcass geometry may lead to an uneven absorbed dose and is pertinent to the low dose aspect of the AMI petition, even though the petition did not provide a definition or criteria to use to define low dose or low penetration. In addition, because absorbed dose is accumulated upon each exposure of treated beef, such treated beef would need to be controlled in a manner to ensure that the total absorbed dose does not exceed the maximum approved absorbed dose. The petition did not address the control of potential multiple application of treatment.

Consequently, FSIS has determined that the petition lacks sufficient detail to warrant investment in development of a rulemaking at this time. FSIS is denying the petition without prejudice. AMI may submit a revised petition for consideration addressing the issues discussed in greater detail in the attachment.

Meanwhile, establishments can use the irradiation treatment on chilled beef carcasses as long as the product meets the requirements of 9 CFR 424.21 for total absorbed dose and 9 CFR 424.22 (c)(4) for labeling.”

The AMI, having waited more-or-less patiently with hat-in-hand for half a decade was disappointed.  Although I’m sure loud cries of anguish and a cuss word or two erupted from their offices late Friday when the letter hit Booren’s desk, James H. Hodges, president, American Meat Institute Foundation, kept his powder dry and politely but firmly responded, “AMI is disappointed that after more than five years of deliberation FSIS has refused to remove a roadblock for the use of a safe and proven technology that can further improve the safety of meat and poultry products. FSIS cites technical reasons for the denial of AMI’s petition to treat carcass irradiation as a processing aid, when the petition simply asked FSIS to initiate the process of making a labeling policy change to encourage the use of irradiation technology.”

Hodges gently pointed out that “All technical issues related to how carcass irradiation is applied could have and would have been resolved during the rulemaking process to allow irradiation to be treated and labeled in the same manner as all other processing aids. Given the substantial food safety benefits this technology has proven to offer, AMI will continue to work with FSIS to resolve these labeling questions.”

In other words, it ain’t over until the fat lady sings and the folks at the AMI aren’t ready to warble. They’ll just dust off their jeans — being a Washington-based association, let’s amend that to say ‘dust off their Brooks Brothers suits’ — reword the petition and resubmit.  Of course, they’ll write themselves a note to check back with the FSIS on July 8, 2016.

A miffed and puzzled Dr. Raymond said, “I think FSIS just blew a chance to make beef even safer than it is right now. If we can blast ground beef with high dose, penetrating radiation, what the heck is behind the reasoning to deny the petition for whole carcass, low dose irradiation to be considered a processing aid? Is this irradiation really more dangerous to my health than carcasses dripping lactic acid, or ground beef being held together by Transglutaminase, or “meat glue?” That stuff got past FDA using GRAS policy and I eat it all the time.”

Knowing the emotionally loaded angles that anti-irradiation groups use and their dogged dismissal of scientific fact, Raymond said, “How many more kids have to suffer and/or die before STOP will say enough is enough? Too many lines have been drawn in the sand for science to have a chance.”

Harlan Clemmons, President of Sadex, the leading provider of e-beam irradiation services – they prefer the term ‘cold-pasteurization — and one of the most vocal proponents of properly used irradiation, differed with Hodges.  Clemmons said the “petition was correctly denied by FSIS because of known and unanswered problems concerning carcass irradiation.”

Clemmons told me that “In 2009, Dr. R. Bruce Miller, the leading authority on food irradiation equipment in the United States, commented to Dr. Dan Schaefer, Director of Research & Development, Cargill Meat Solutions, that in Dr. Miller’s opinion, it is probably NOT possible to even create an e-beam irradiation system that could accomplish carcass irradiation. . .because of the irregular shapes, sizes and folds in carcasses.”

“I agree with AMI,” Clemmons said, “when it stated that irradiation is a safe and proven technology that can further improve the safety of meat and poultry products.”

Clemmons looks at the use of irradiation differently than the folks at AMI. Fearing the problems he believes are inherent with the irregular shape of beef carcasses, he wants the process used later in the production and distribution system.  “Properly applied food irradiation of the final packaged food product in a validated and verified HACCP plan will reduce lethal mutant and antibiotic resistant strains of E. coli, Campylobacter, Salmonella, and Listeria to non-detectable levels in final packaged food products,” he said. (The emphasis is his.)

Let me take a heavy and a ragged but deep breath here. This is not an easy subject to write about. Talking about it is even harder. This interview is about the needless death of children and I can think of nothing in life that’s worse than watching your baby die.  

From those supremely tragic events came an organization known as STOP. The letters stand for Safe Tables Our Priority. Numbered too heavily among its founders are people who have lost children to food borne illnesses.  

Nancy Donley is one of them. She was a protective mother of young Alex, her only child.  Some might have even called her ‘over-protective.’  But it didn’t matter.  In the end, she lost her six-year old son to hemolytic uremic syndrome (HUS) caused by eating an undercooked hamburger during a family picnic.

HUS is a complication associated with Escherichia coli 0157:H7, a bacterium found in cattle feces.  Estimates place E. coli infections at more than 70,000 people every year, mostly from eating tainted food such as raw field greens and undercooked ground beef.  Healthy people usually survive after a bout of diarrhea, but up to 500 people don’t.  They die a painful death and it is children, pregnant women, the elderly, and the chronically ill who are the most vulnerable because of their weaker immune systems.

STOP has been among the most vocal and influential groups demanding a stronger food safety system. Too often, though, they found their arguments thwarted by other groups whose special interests run counter to theirs. Recently, a confluence of food safety-related news stories made this interview an absolute necessity.

Here’s the list: A rash of food recalls leading into the always more dangerous summer months; the USDA’s announcement that ‘Test and Hold,’ an overdue industry-backed initiative, might finally attain regulatory status; the new food safety bill and the debate over its funding, the Tester amendment that frees small businesses from oversight — catch my drift?  

Here is an interview that you should skip only if you don’t eat food:

Q. Let’s start by talking about STOP and its reason for being.  Why was it founded and what is its goal? 

A. STOP was founded in the aftermath of the 1992-93 West coast foodborne illness outbreak from E. coli O157:H7-contaminated hamburgers from a fast food restaurant chain.  Over 700 people were sickened and a known four children died in this outbreak.  This was the watershed event that catapulted the issue of food safety to national attention.  

STOP’s founders included family members of those stricken, including the mother of the first child to die in the outbreak.  STOP was founded in large part to find answers to fundamental questions such as how can such a catastrophe occur; what food safety gaps and/or loopholes exist that need to be filled; and what measures, if any, are in place to prevent this from occurring again?  

We were then, and still are now, committed to the enactment and enforcement of public health-based food safety policies that will prevent contaminated food from entering the marketplace.  STOP’s mission is straightforward: to prevent illness and death from foodborne pathogens.

Q. You first talked about STEC’s 3 ½ years ago in a speech commending the “FSIS, FDA and the CDC for working together on the need to address non-O157 STEC in our food supply.”  Your comment was “It would be unusual — to the point of delusional — to think that disease-causing non-O157 STEC would veer from the same paths of contamination that occurred with O157.”  

Yet several years would pass and Bill Marler would have to spend half a million dollars of his own to test meat samples before the government and the public would really focus on the problem.  How did the ball get dropped?

A. I don’t really know if the ball was actually ever really dropped; certainly the CDC never backed down from its position of concern regarding the public health risks associated with non-O157 STECs, and Marler and STOP never backed down on advocating the need for them to be declared adulterants. 

I do think that there have been attempts to shelve the issue due to resistance of some in the beef industry.  The American Meat Institute’s August 18, 2010 letter to Secretary Vilsack strikes me as a thinly-disguised attempt to stall the momentum of getting regulatory programs enacted to prevent meat products contaminated with these other pathogenic strains of E. coli from entering commerce.  

I am heartened by Undersecretary Hagen’s recognition of the public health risks these strains present in meat products that are her responsibility to regulate.  STOP continues to press for the need for these strains to be declared adulterants so that, as with O157, companies will have to account for it in their HACCP plans, routine microbial testing will be conducted and positive findings result will result in product diversion to cooking or in a recall as the situation merits.

Q. The Obama administration seems to have a stronger focus on food safety than [the] previous administration.  With the creation of the Food Safety Working Group and the appointments of people like Dr. Margaret Hamburg and Dr. Elisabeth Hagen to key offices, are you encouraged by this new activity?

A. We applaud the appointment of individuals with a public health background to leadership positions within public health agencies.  We are relying on their commitment to public health to promote policies that will better protect consumers. 

That being said, these agencies need appropriate funding to be able to adequately implement and enforce robust food safety programs.  It remains to be seen if they will get the resources they need to perform to a level that will enable them to maximize public health benefits.

Q. Let’s talk about two closely related events: the new food safety bill which has been called the most sweeping change since 1938, and the threatened tax cuts that could derail it.  First; did the new bill go far enough? 

A. STOP appreciates the preventive approach of the FDA Food Safety Modernization Act which, by design, requires FDA to take a proactive approach to food safety for the foods that it regulates rather than the reactive mode that it has operated from in the past.  

That said, as an organization that represents those personally impacted by unsafe food, it was really difficult to stomach the legislative process and how elements within the bill meant to protect public health got watered down by special interest groups. The Tester language exempting certain entities from the law is an example.  We maintain that all entities, regardless of size, must be subject to the same food safety laws and regulations. Contamination can occur at any size facility and none should be exempt from having to have measures in place to better protect public health. 

Q. And second; the economic downturn of the past two years put extreme pressure on the federal budget and there is a strong drive to cut spending, including the funding needed to fully enact the law. Acknowledging that an overall reduction in spending is probably necessary, should food safety be part of that cutback?

A. Protecting public safety should have the highest priority in how our tax dollars are spent and food safety should be at the very top; ever
y single person must eat. &n
bsp;Unfortunately, that’s not how decisions are necessarily made in Washington.  

The new FDA bill started out with budgetary constraints to begin with and will be the victim of a double whammy if the Congress doesn’t fund it. The initial bill had a more robust inspection frequency which got curtailed because of budgetary concerns.  So now we have a watered-down inspection frequency that stands to take a second hit if funding isn’t made available for FDA to perform even to the level that finally made it into the final bill.

Q. Let’s compare and contrast the state of our food supply today vs. where it was when STOP was founded.  Where has the industry succeeded and where has it failed?

A. I think that many in both industry and government have come a long way in recognizing the need to be proactive in food safety. I remember vividly sitting in the back of USDA’s cafeteria during the public meetings on the proposed PR/HACCP rule with members of the meat industry and government and how the dynamics were so different then than they are today.  

Back then, everyone was pointing fingers at everyone else as to who was responsible for the safety of food.  I honestly think that those days are over for the majority of the parties; that most recognize that it’s the pathogens and not each other that is the “enemy” and that we all have a role to play in not letting the “enemy” be the victor.   

Industry leaders that have been innovative in fostering continuous food safety practices and technologies deserve applause and recognition.  Industry laggards and those in denial of their responsibilities should get out of the business and do something else.

My personal “wish” as STOP’s president is to render our reason for existence obsolete; that contaminated food will be a thing of the past and innocent people will no longer have to suffer and die from unsafe food.  

I said that this was my “wish” and not my “goal” because I do understand all too well that there is no such thing as a guarantee and that food will never be completely safe.  However, we must continue to strive for ever-safer product.  On behalf of STOP, I want to thank all of you who embrace the goal of a safer food supply and who just don’t talk about it … but work at it.  

The Agriculture Department proposed rules Tuesday that would force companies to delay shipments to consumers until government inspectors have released tests on the meat. The department’s Food Safety and Inspection Service (FSIS) has inspectors in all meat plants that sample for E. coli and other contaminants.

Currently, products that are sampled can be shipped before testing results are known, though many companies already have procedures in place to hold the meat. The agency said at least 44 recalls between 2007 and 2009 could have been prevented if the rule had been in place.

So I had to take a deep breath.  As an old friend often said about complicated issues, “I feel strongly both ways about that.”

To ship meat that’s been sampled and tested before the results are in always seemed to be a fool’s errand to me.  Yeah, 99 times out of a hundred, it’s a wise financial decision.  The odds are overwhelmingly in favor of loading up the truck and sending it on its way.  The money saved by not sitting on tens of thousands of pounds of inventory for a few days can put a nice smile on a CFO’s face in a low margin business.

On the other hand, one slip can be fatal and the USDA counted 44 slips in just two years.  The financial hit a meat processor will have to take while managing a recall can make that erstwhile smiling CFO look for a ledge on the top floor of a very tall building.  Even if the business has the immediate reserves to survive a massive, cash-sucking, soul-searching recall, the blow to the corporate reputation can lead to certain death.  Customers lost because of a recall seldom return.

I remember an advance man for one of those flying military shows — Blue Angels, I think — telling me how safe their aerial acrobatics were and why they chose to fly in certain areas.  It was more than 20 years ago, so forgive me if I have to paraphrase.

“Those boys are highly trained,” he said.  “They spend thousands of hours perfecting their skills and the odds of an accident are a hundred thousand to one — easily.”

“Still, they ‘ain’t’ perfect and they can screw up.  That’s why we like to do these maneuvers over lightly populated areas.  If they augur in while training over the Mojave Desert, we’ve got a mess to clean up and a few snakes and lizards on the ground meet their maker.”

“If they smack down while executing a stunt over downtown San Francisco on the Fourth of July, not only have we lost some excellent pilots but maybe thousands of citizens on the ground.  Why take that risk, no matter how small?”

That’s exactly the risk a meat processor takes when he ships before he sees the results.  The skinny, minuscule, almost non-existent chance that the worst case can happen almost certainly will lead to a major disaster.

Lisa Keefe, writing in Meatingplace, an industry news resource, pointed out that the USDA was acting on a petition that was first submitted to the USDA by the American Meat Institute three years ago and it would give the Food Safety and Inspection Service the authority to hold the products until FSIS test results are received.

Stealing a Martha Stewart quote, let me say “It’s a good thing” that AMI and the meat industry have taken a leadership position on this issue.  Too often, the industry is seen as dragging its feet on food safety proposals that might take a few dollars off the bottom line.  In this case, I have to wonder why the USDA sat on the AMI proposal for three years.

A statement given to Meatingplace by AMI President J. Patrick Boyle said, “We are pleased that USDA has indicated that it will make mandatory our voluntary test and control procedures. We believe that this policy will prevent needless recalls, further ensure food safety, and maintain consumer confidence.”

Phil Kimball, executive director of the North American Meat Processors Association, said in a statement provided to Meatingplace, “NAMP supports the proposed change in the FSIS ‘test and hold’ policy, and has encouraged our members for many years now to follow ‘test and hold’ practices to better protect consumers and their businesses.”

Kimball added a word of caution, though, saying “As we analyze the policy put forth by FSIS, we want to ensure that FSIS works with processors, particularly small and very small processors of fresh products, to ensure that representative samples can be taken without disrupting the company’s ability to fill their daily orders.”

The bottom line: To make this proposal work in the real world, tests are needed that are quicker and more accurate.  They’re coming; the lab rats of the world are working feverishly on something that’s as near immediate as possible.  What we also need is a well-funded USDA that can put highly trained and skilled personnel on the floor to test and return the results at near the speed of commerce, regardless of the method of choice.

Reading through Fong’s prepared notes, Food Safety News reporter Helena Bottemiller caught something that should make the meat industry take immediate notice, though. Early in her presentation, Fong surmised that the deeply debated N-60 testing regimen, the one that was supposed to make detection of E. coli 0157:H7 much better, wasn’t working. 

With N-60 in its infancy, a comment like that by almost anyone else might be labeled as grossly premature and dismissed immediately. Quoting President George I, though, “It wouldn’t be prudent.”

Here is what General Fong said: “…we recently completed an audit that assessed how the Food Safety Inspection Service (FSIS) samples beef trim for E. coli, which can contaminate products such as ground beef.  Currently, FSIS’ inspectors take 60 samples from large lots of beef trim to test. We found, however, that this procedure does not yield a statistical precision that is reasonable for food safety.” 

Explaining herself, she said, “Although 60 samples may be adequate to detect widespread contamination, more are needed when E. coli is less prevalent. FSIS’ current sampling methodology results in detection of E. coli less than half the time when it is present in 1 percent of a beef trim lot. Accordingly, we recommended that the agency place its testing process on sounder statistical ground by redesigning its sampling methodology to account for varying levels of contamination.”

And to explain why dismissing her comment isn’t a wise course of action, she concluded this part of her presentation by claiming, “FSIS generally agreed with our findings and recommendations. In related audit work, we have initiated a review of the agency’s E. coli testing protocols to ensure that beef trim is effectively collected and analyzed. Together, our beef trim sampling and testing audits should help bolster public confidence that FSIS’ tests are accurately identifying E. coli and ultimately preventing contaminated meat from being distributed and consumed.”

What is most alarming is Fong’s assertion that as the industry gets better at eradicating E. coli O157:H7, they need to ramp up their testing and look harder for an ever decreasing contaminant. 

The first alarm bell that went off in my head was a comment made years ago by a food scientist friend.  In the early days of the E. coli panic, shortly after the Hudson beef recall that started the stampede toward HACCP programs, I asked him about the validity of testing.

“Give me 2,000 pounds of beef trim and enough time and I’ll find E. coli in there somewhere,” he said.

Of course, that was a lifetime ago, when we were all just waking up to the threat of this pathogen and discovering how prevalent it was. Billions of dollars spent on research, millions of pounds of recalled product and the development of multiple kill steps, and we’ve all learned a lot about identifying and controlling E. coli. Today, my food scientist friend might literally test every ounce of that beef and come up empty.

But Fong’s fear is that he might not strike out.

So let’s ask this question – if 60 isn’t enough, how many samples do we need to take?

I asked ex-USDA Under Secretary of Food Safety Richard Raymond if he had read Fong’s comment.  “Yep, I had read it,” he said, “and I don’t necessarily disagree and already have a blog working its way from my mind to my PC on it.”

About the proper testing regimen, he said, “I am not a statistician, so I really cannot tell you what amount of testing reduces the risk to what level, but we all agree that the more you test, the more you will find.”

“My question is, what will it cost to reduce the risk just a little bit more? Raw beef will still be a risk, it won’t be risk free. If we cut the risk in half, what impact will that have on illnesses and deaths if consumers continue to not understand that raw beef must be handled and cooked with care?”

Dr. Jim Marsden, Regents Distinguished Professor of animal sciences at Kansas State University and Senior Science Advisor with the North American Meat Processors Association, agreed with Dr. Raymond.  “The problem is that due to non-uniformity in distribution and the very low incidence of E. coli O157:H7, no amount of testing will provide an acceptable statistically significant confidence interval,” he said.

Raymond talked about the inception of testing trim. “Just a few years ago, we were not testing trim at all,” he said. “We began this process back in about 2006 or ’07 – lots of testing, lots of dollars. What did that testing do to the number of positives in ground beef, in illnesses, etc.?  Not very darned much. Seventy people died from E coli last year. Twenty percent of E coli outbreaks were linked to ground beef. The rest were produce, drinking water, person to person, recreational water.”

“Should we really invest more money on testing or should we invest it on processing aids like low dose irradiation of whole carcasses and/or pre-harvest interventions (vaccines) that will reduce the risk more than more testing? $400 million will vaccinate every cow in this country, reducing not only E coli in ground beef, but also on the ground, in the rivers and ponds, and thus reduce the illnesses from petting zoos, recreational water, drinking water, lettuce and spinach.”

Dismissing Fong’s politically correct call to greater action with hard facts, Raymond suggested a different approach that promises a better outcome. “Demanding more testing is the easy way to look good for and to the consumer advocates. Demanding a more sweeping but debatable intervention is tougher sledding. And does not produce as many sound bites.”

And it would be premature to take the step she’s suggested. For the first two months of 2011, there have been 1,775 samples pulled at the federally inspected plants producing raw ground beef and none have proved positive. That’s zero percent so far, although we can expect a few positives during the usually more active summer months. In 2009, FSIS pulled 12,797 samples and found 36 positives for an amazingly low 0.28 percent, compared with 0.44 percent in 2008. 

The downward trend may be approaching the point where no amount of additional testing – other than N-100 percent – will find additional positives. In other words, ground beef, which has the potential to be a dangerous food if handled improperly, has become one of the safest foods on our dinner plate.

Dennis R. Johnson, a principal with the Washington, D. C. law firm of Olsson Frank Weeda and a specialist in food safety law and regulation, responded on behalf of several other people I contacted. Johnson represents large and small meat and poultry companies and trade associations before the U.S. Department of Agriculture’s Food Safety and Inspection Service.

Responding to Fong’s review of N-60 sampling, he pointed out that the meat industry “met Healthy People 2010 goals for E. coli O157:H7 in 2004 and 2009. In each and every year, the incidence was below the Healthy People baseline. We note that this is the only Healthy People pathogen reduction goal which has been met.”

Agreeing with Dr. Marsden, Johnson said, “With a non-uniform, non-random organism present at a ver
y low incidence rate, there
would never be enough samples per lot to provide an acceptable statistical significance. It is simply impossible to test food safety into the system. Unfortunately, OIG focused on the effectiveness of N-60 solely as a lot release program, given the precise question posed by the Congress.”

Johnson sees N-60 as a verification tool to measure process control. He said “In 2002, the annual trim incidence rate for some in industry (using a less robust sampling program) was 1.76%; in 2010, even using the more robust N-60, the rate was less than 0.15%. Beyond the historical data, establishments also view the results of the day to determine whether there is a basis to question any negative finding. These factors were not considered by OIG in its assessment of N-60, so its assessment is ‘flawed.’ “

Does N-60 work as intended?  Johnson thinks it does. “Perhaps the most telling statistic,” he said, “is that in the 17 foodborne outbreaks since 2006 involving E. coli O157:H7 with which I am familiar, in only one was raw material from an establishment conducting a 375 gram N-60 excision trim even in the blend suspected of causing illness.” 

“I am not a statistician,” he said, “but the odds of 50% of the raw materials only appearing once in 17 events are extremely low. N-60 has a demonstrated benefit when measured by the statistic that truly matters – improved public health.”

Moving the mark significantly forward might require tactics that aren’t so attractive to the politicians who write the rules and regs because many segments of the public irrationally fear those tactics. For instance, the USDA, fearing public reaction, has been sitting on the AMI’s petition to approve irradiation as a processing aid for chilled beef carcasses for 5½ years.  The FDA approved its use for iceberg lettuce and spinach in 2008 and managed to weather the storm. The feds behind it and the produce industry survived. Surely the USDA can take the same path. 

It was six years ago that the world first saw a clear example of the damage that dioxins can cause. The face of former Ukrainian President Viktor Yushchenko was heavily scarred, the effect of a chloracne outbreak after suspected dioxin poisoning. He might have been poisoned with as little as a drop and significant amounts of poison could remain in his system for the rest of his life. 

Wikipedia paints a much scarier portrait of the 70+ isomers of highly toxic, man-made organic compounds. Byproducts of some industrial processes and waste incineration, “dioxins are fat-soluble, so they tend to accumulate in the tissues of the animals who encounter them and it can take many years for the compounds to break down. Any person living in an industrialized country has dioxins in his or her body–we ingest them when we eat animal fats or animal-fat byproducts.” 

The online information source says “It’s unclear how harmful these low doses could be. Some animals begin to show symptoms of poisoning when they’re given doses only two or three times the level of dioxins in the average person’s body. At higher concentrations, though, there is no doubt about its severity: Dioxin poisoning can cause organ disease, an increased risk of cancer and heart attacks, a suppressed immune system, hormonal imbalances, diabetes, menstrual problems, increased hair growth, weight loss, and, most obviously, the facial cysts known as chloracne. 

When German health officials found traces of dioxin in feed supplies in early January, they immediately banned eggs, pork and poultry and ordered the destruction of 8,000 chickens and a temporary ban on more than 1,000 farms from selling eggs.  For the public, the ban quickly grew from a temporary inconvenience to a full-blown food crisis when the ban expanded and more than 4,500 farms were closed.

News reports coming from the EU say dioxin contamination was traced to animal feed laced with industrial fats that were substituted for vegetable fats at some point in the manufacturing process. The contamination was extreme–up to 77 times acceptable levels of dioxin were present in samples taken at Harles and Jentzsch, the firm at the center of the scandal over contaminated animal feed.  The company had accidentally mixed oils intended for use in biofuels with oils intended for animal feed.

Concerned European Union officials have already called for stricter regulations and more severe penalties, putting increased pressure on food manufacturers to use more sensitive detection instrumentation.

In a move that could signal similar restrictions in the U.S., German Agriculture and Consumer Protection Minister Ilse Aigner unveiled a 10-point plan to safe-guard animal feed.

“We will significantly increase safety standards and sharpen obligations to notify authorities and the duty to inspect,” she said. “Consumers expect this and we are going to do it.”

The plan calls for:

1. Feed producers to obtain product and ingredient authorization. 

2. Separation of production flows. 

3. Expansion of legal requirements for feed production. 

4. Private laboratories to report and positive tests. 

5. A binding positive list of feedstuffs. 

6. An obligation to cover liability. 

7. Revision of the system of penalties. 

8. Expansion of dioxin monitoring to establish an early-warning system. 

9. Improvement of the quality of food and feed controls and inspection. 

10. Transparency for consumers. 

“It will kill back yard gardens,” they say.  “It will make food production so expensive, the small guy will be put out of business,” is another complaint.  “It’s just a ploy by big ag and big food to kill off the little guys.”

No, nothing in the bill even comes close to saying that.

Or this one: “My mother cooked for our family for years and sold home-made jams at the church.  No one ever got sick.”

I don’t think so.  Your mother was either incredibly lucky or you have a memory problem.  Sorry.

Or this one: “It’s only the big guys that make those mistakes that sicken thousands.  There has never been an instance of a small producer poisoning customers.”

Stuff and nonsense. 

After the recent recalls and refusals to recall–all for foods made by boutique or artisanal food processors, I looked at cases of foodborne illnesses over the last decade.  Bravo Cheese, the Costco supplier that produced a E. coli-tainted product that sickened at least 38 people in the Southwest and just pulled all their cheeses because of E. coli and Listeria, immediately came to mind.

And then there is Estrella Family Creamery, the Washington state-based artisan cheese maker that’s the latest darling of the ‘free my food’ crowd.  The owner actually refused an FDA request to recall its cheeses after its facility and products were found to be contaminated with Listeria, a potentially fatal pathogen for the elderly, children, pregnant women and unborn babies. 

I hope her pockets are as big as her cojones because, sooner-or-later, a lawyer is going to call on her and it will be hard to imagine any jury that won’t convict.

Even more, I hope her refusal starts a public outcry for the FDA and the USDA to have the legal right to force a recall, not just make a polite and toothless request.

Checking in with Bill Marler, the attorney who dominates the “sue the bastards” business and who probably has the most direct pipeline to the companies that get caught on the wrong end of food safety issues, I found these recent perps, all brought down by E. coli 0157:H7:

• AFG / Supervalu E. coli Outbreak – Minnesota

• Aunt Mid’s Lettuce E. coli outbreak – Michigan, Illinois, and Ontario

• Bauer Meat E. coli Litigation – Georgia

• BJ’s Wholesale Club E. coli Litigation – New York and New Jersey

• California Romaine Lettuce E. coli Outbreak – Washington State

• Camp Bournedale-South Shore Meats E. coli Outbreak – Rhode Island, Massachusetts

• Captain’s Galley Seafood Restaurant E. coli Outbreak – North Carolina

• Cargill E. coli Outbreak – Nationwide

• Carneco / Sam’s Club E. coli Outbreak – Wisconsin & Michigan

• ConAgra Ground Beef E. coli Outbreak – Nationwide

• Dole Lettuce E. coli Outbreak – Minnesota, Wisconsin, and Oregon

• Dole Spinach E. coli Outbreak – Nationwide

• Dungeness Valley Creamery E. coli Outbreak – Washington state

• Emmpak E. coli Outbreak – Wisconsin

• Excel E. coli Outbreak – Georgia

• Fairbank Farms E. coli Outbreak – New England

• Flanders Provision Co. E. coli Outbreak – Colorado, Nationwide

• Forest Ranch Fire Department Fundraiser E. coli Outbreak – California

• Freshway Lettuce E. coli 0145 outbreak – Michigan, Ohio, New York, Tennessee, and Pennsylvania

• Fresno Meat Market E. coli Outbreak – California

• Gold Coast Produce E. coli Outbreak – California

• Golden Corral E. coli Outbreak – Nebraska

• Habaneros E. coli Outbreak – Missouri

• Herb Depot & Autumn Olives Farm Raw Milk E. coli Outbreak – Missouri

• Interstate Meat E. coli
O157:H7 Outbreak – Oregon, Washington & Idaho

• Jack in the Box E. coli Outbreak – Western States

• JBS Swift E. coli Outbreak – Nationwide

• Jimmy John’s Gourmet Sandwiches E coli Outbreak – Colorado

• Karl Ehmer Meats E. coli Outbreak – New Jersey

• KFC E. coli Outbreak – Ohio

• Kid’s Korner Daycare E. coli Outbreak – Missouri

• Kindercare E. coli Outbreak – California

• King Garden Restaurant E. coli Outbreak – Ohio

• Lane County Fair E. coli Outbreak – Oregon

• National Steak and Poultry E. coli O157:H7 outbreak – nationwide

• Nebraska Beef E. coli Litigation – Minnesota

• Nebraska Beef E. coli Outbreak, 2008 – Nationwide

• Nestle Toll House Cookie Dough E. coli Outbreak – Nationwide

• Odwalla E. coli Outbreak – Western States

• Olive Garden E. coli Outbreak – Oregon

• Organic Pastures E. coli Outbreak – California

• Parsley E. coli Outbreak – Washington & Oregon

• Peninsula Village E. coli Outbreak – Tennessee

• PM Beef Holdings, Lunds & Byerly’s E. coli Outbreak – Minnesota

• Robeson Schools E. coli Outbreak – North Carolina

• Robinswood Pointe Senior Living Facility E. coli Outbreak – Washington

• Rochester Meat Company E. coli Outbreak – Wisconsin, California

• Rocky Mountain Natural Meats Bison E. coli outbreak 2010 – Colorado New York

• S & S Foods – Goshen Boy Scout Camp E. coli Outbreak – North Carolina

• Sizzler E. coli Outbreak – Wisconsin

• Sodexho Spinach E. coli Outbreak – California

• Spokane Produce E. coli Outbreak – Washington, Oregon, Idaho

• Stop & Shop E. coli Case – New Hampshire

• Taco John’s E. coli Outbreak – Iowa and Minnesota

• Topps and Price Chopper E. coli Case – New York

• Topps Meats E. coli Outbreak – Nationwide

• Totino’s and Jeno’s Pizza E. coli Outbreak

• United Food Group E. coli Outbreak – Western States

• Valley Meats E. coli Outbreak – Ohio, Illinois, Pennsylvania

• Washington County Fair E. coli Outbreak – New York

• Wendy’s E. coli Outbreak – Oregon

• Wendy’s E. coli Outbreak – Utah

As they say on late night TV, “But, wait!  There’s more!” but I won’t take you there.  I think a full page-and-a-half makes my point.  If you scan that list, you’ll find businesses of every size and product mix; meat, produce, dairy, restaurants, schools, senior living facilities, they are all there.  Selling food that carries pathogens causing potentially fatal food borne illnesses is an equal opportunity proposition.

The big boys have in-house labs and scientists and access to the latest technologies to help them produce safe foods and they still fail from time-to-time.  The little guys too often don’t have access to any of those safety backstops and while a problem at Karl Ehmer Meats might only effect a few thousand people in one state, while an error at Cargill can touch the lives of millions all across American, one grievously ill child or a dying grandparent is still one too many.

What scares me more than the Cargills of the world making production errors when they have access to the latest science and all the tools they need is the prospect of hundreds of boutique and artisanal producers with no idea that their output might be contaminated.  They lack the knowledge and the chances that someone from the government might actually cross their doorstep and ask a pointed question or two is almost non-existent.

And, yes, before I get bombarded with incredible rants that this artisan or that boutique produces only the most wholesome product and takes better care of their output than a Cargill ever could, I know the vast majority of those businesses are run by serious, conscientious people.

But as Mark Mina, DVM, an FSIS Deputy Administrator, Field Operations, once said during the early days of the huge Hudson Meat ground beef recall in 1997, “There are two types of business out there, those that have had a recall and those that will have a recall.”

So should anyone putting a food item into commerce get a free pass because he or she runs a business that’s “too small to afford” the proposed food safety requirements?  Absolutely not.  If the business is too small to afford the necessities, it is definitely too small to afford the kind of payment Cargill is making to Stephanie Smith.

Editor’s note: With Senate action on the Food Safety Bill approaching, we received more opinion pieces than we had space in our format, so these contributions from Chuck Jolley and Roland McReynolds are being posted in the news section.

The AIB inspections took place between 2007 and 2010.  It’s important to note that AIB had also inspected Peanut Corporation of America, the morally and fiscally bankrupt corporate outlaws that repeatedly shipped Salmonella-infected peanuts, peanut butter, peanut meal, and peanut paste to institutional users such as schools and nursing homes, and to food processors in 2008 and 2009.  Concerns about sanitary conditions in that plant had been expressed by some of their customers and others for about 20 years before the ax finally fell.

About Wright County Egg, AIB said, “Inspection results over this period in the three grading/sorting operations include observations that range from unsatisfactory, serious, needs improvement, to minor issues in the area of personnel practices, maintenance, and integrated pest management,” adding that internal reviews of inspection reports established that Wright County met the requirements of the AIB International 2008 Consolidated Standards for Inspection.

As part of the inspection, the AIB said its auditor queried the Wright County Egg operators about the environmental microbiology and finished product tests and confirmed that they were compliant with current U.S. Department of Agriculture regulations.

USDA and FDA inspectors also passed through Wright County Egg from time to time and, after several years of urging WCE management to do the right thing, the FDA finally reported finding about “eight frogs living under one egg-laying house, wild birds flying inside houses, pigeons roosting in an air vent, unsealed holes appearing to be rodent burrows, live mice, ‘live and dead flies too numerous to count’ and ‘live and dead maggots too numerous to count.’ Live flies were on and around egg belts, feed, shell eggs and walkways. Live and dead maggots were observed in a manure pit.”

Four to eight feet of chicken manure below egg-laying operations was observed in some locations.

Manure up to eight feet deep?  The ammonia had to be way above OSHA standards.  Were employees adequately protected with filtered breathing equipment?  Probably not.

OK, let’s total up the damage here and figure out which organization has the most egg on its face.

1.    AIB, probably the premier organization when it comes to sanitation and food safety, was in and out of Wright County Egg and, despite some concerns, gave WCE a passing grade.

2.    USDA was also in the neighborhood and despite some concerns, gave WCE a passing grade.

3.    FDA slapped WCE’s corporate hand a few times but allowed it to continue to operate.

4.    WCE has a lengthy rap sheet of all kinds of corporate offenses, courtesy of many state and local officials, none of whom were willing to blow the whistle.

Doesn’t it sound like everyone involved in this mess spent years doing their best imitation of Sgt. Schultz from Hogan’s Heroes?   “I see NOTHING!“

It was only after the Salmonella issue got way out of hand and an unknown but certainly large number of people were sickened that the FDA played its trump card.  With hat in hand the agency went to the head of WCE and said, “Please Mr. DeCoster, sir, would you consent to recall a little over half a billion eggs?  We think a few of them might be killing people.”

You have to understand this: The FDA does not have the authority to demand a recall, no matter how grievous the threat might be.  Neither does the USDA.  They can only make a request; the company in question doesn’t have to comply.  The USDA can exercise its option of pulling its inspector, though, which can effectively shut down a plant’s operations.

Of course, a facility has to be inspected first, to know that something is amiss.  Last year, the Office of the Inspector General reported that over half the facilities registered with the FDA haven’t been inspected in at least five years.

The food safety bill that’s currently being held captive by one lone Senator who would rather play politics than save lives will give the USDA and FDA more of the tools they need to do their jobs.  With its passage, the extra dollars will help staff the two organizations with more people so they have a better chance of catching the PCAs and WCEs of America’s food processors before they do damage.  And we will once again make truthful this hackneyed old phrase: “In America, we enjoy the world’s safest food supply.”

Bottom line: Senator Tom Coburn’s adamant refusal to allow the food safety bill to go to a vote or even to work with the majority of the Senate to reach a compromise is one of the most venal political maneuvers in decades.  He’s putting his “just say no” attitude in the way of a bill that can help significantly reduce illnesses and deaths caused by foodborne pathogens.  The health and lives of thousands of people are being held captive by the bad gentleman from Oklahoma.

Michael Sansolo was the chief honcho at the Food Marketing Institute for a long time before he left and joined forces with Kevin Coupe and MorningNewsBeat.  He writes a column for that supermarket-oriented news and opinion service called “Sansolo Speaks.”  Recently his editorial comment was entitled “When Logic Fails” and one paragraph especially should be read by everyone in the food industry trying to sell the science behind the food safety issue.

“We have to remember that in the battle between intellectual and emotional arguments, the latter wins nearly every time.  We have to remember that thinking we are right or thinking we’re doing the right thing doesn’t matter unless our customers get it and respond. Most importantly, we have to stop our internal group-think and actively seek outside voices that might be willing to tell us we are wrong.”

To all the trade associations and food businesses that insist science is on their side: “Yeah, so what?”

Having science on your side is only good as long as the public believes and, too often, they don’t believe.  They’ve seen “the science” change as new facts come to light.  They’ve seen ‘”the science” bought and sold by special interest groups.  A simple Google request can show you research by esteemed scientists that can prove both sides of almost every issue.  Further Googling usually turns up some interesting information on who paid for the research.

Just as bad meat can’t pass the sniff test, tainted research also stinks but the odor is usually well-disguised and a little harder to sniff out.

The painful fact: It’s an open secret that there are scientific hired guns waiting out there to make a buck.  Want some research to prove your point?  Go see Dr. A.  Need some research to disprove that same point?  Dr. B can help.

So I’m not shocked that most people go with their gut feeling on most issues.  It’s a scientifically invalid gut, to be sure, but for them, it is the absolute truth.  Arguing with those people who have made up their minds does absolutely no good, especially if your argument is based solely on the science.

An uncomfortable truth: What most people accept as “sound science” often is just “shaky science” that backs up their own preconceptions

Using science alone as a debating point turns your argument into a useless exercise in preaching to the choir.  You’ll sound great but all those “Amen, brother” comments from the crowd are coming from the previously converted.  All your friends and relatives will high five you, pat you on the back and nod in vigorous agreement.  Everybody sitting outside your party tent will just roll their eyes and mutter something about “sipping the Kool-Aid.”

A message to aggrieved associations and food processors: Follow Sansolo’s advice.  Stop the internal group-think and seek out people with opinions that conflict with yours.  Find out why they think you’re way off base and work with those arguments.  Some will be based on the science – their science, not yours – but most will be based on emotion.  Fight science with science but understand that the gut almost always wins the argument.  If you can’t speak to that part of their anatomy and understand its power, you’ll lose the debate every time.

The core of Sansolo’s editorial is this: “thinking we are right or thinking we’re doing the right thing doesn’t matter unless our customers get it and respond.”

Too often when it comes to issues of food safety, your customers don’t get it and they are responding in ways that should cause you to stop and “point with alarm.”  They might intellectually understand that only one meal in a million can make you sick, and the food industry can “point with pride” at those statistics.  They feel with their hearts, though, when little 5-year-old Anna dies an agonizing death from massive organ failure brought about by E. coli-tainted meat.

And as far as most people in the general public are concerned, there is no justification for that tragedy.

But the industry’s efforts still have a problem and it’s one of perception.  I’ve often said the science behind what the industry does is sound and trumps the emotional appeals used by anti-meat groups.  Those emotional appeals, unfortunately, often win the day and here’s why:  People eat with their hearts and souls.  When a family member is struck with a foodborne illness and lingers near death, people react to the tragedy with their hearts and souls.  They take no comfort in the fact that only an incredibly small proportion of meals result in illness or premature death.  They take even less comfort in the fact that a number of those deaths and illnesses might have been due to food mishandling on their part.

Case in Point: Back when I was teaching a course on crisis management for the meat industry and using real world incidents as discussion points, one of the people in the class got overly agitated about the public relations fall out caused by the death of a young boy.

“Why should my company have to suffer when it’s clear that the cause was undercooking food in the home?” he exclaimed.

I said, “Would you like to stand up in front of a group of reporters, point to the grieving mother and tell them that it’s all her fault?  That she actually killed her five-year-old?”

A comment like his comes across as cold and unfeeling.  It’s business suicide.  And as Jim Marsden, a well-known and highly respected meat science researcher at Kansas State University said, “‘Just cook it’ isn’t the answer.”

Here is a harsh, non-scientific fact:  Science can only take you so far with the public.  There comes a time when emotion takes the argument.  With all the work the food industry has done to eliminate foodborne illnesses, it’s often seen as lacking in resolve.  The food industry has to appear to take charge of the foodborne illness issue and not be seen as dragging its feet.  The AMI letter sent to USDA Secretary Vilsack sends the wrong emotional message.

The letter says, “Designating non-O157:H7 shiga toxin-producing Escherichia coli (STEC) as adulterants would result in a regulatory program that will do more harm than good.”  

The public will ask, “For whom?  My family or the meat business?”

AMI took the position that “Non-O157:H7 STEC’s in beef products may be a reason for potential public health concern, but it is not a public health emergency.”

The public will say, “For my children, a potential public health concern is a public health emergency.”

The letter outlined 8 specific steps that the USDA should complete before considering STEC’s as adulterants:

1. Focus on Prevention
2. Conduct a Comprehensive Public Health Risk Assessment
3. Validate Analytical Laboratory Test Methods
4. Conduct a Baseline Survey of Non-O157:H7 STECs on Beef Products
5. Measure Progress Based on the Public Health Outcome
6. Expedite Approval of New Microbial Interventions
7. Determine Impact on International Trade
8. Provide an Open and Transparent Public Policy Process

All eight are valid points that need to be addressed as quickly as possible.  Steps #3 and #6 are especially critical.  Even if the USDA were to take an immediate step of declaring STECs to be adulterants, there are no valid tests or preventive technologies available.  If a processor can’t test for STECs and eliminate them when present, the government can’t force the issue.

But I can see it coming already.  Critics will immediately jump on the points made in the letter as just another effort by the meat industry to shirk its responsibility; to make food safety a financial, profit-and-loss decision and take the focus off of it as a serious public health issue.  The AMI hit the science squarely on the head but missed the emotional issue completely.

In one of his periodic Meatingplace.com blogs (subscription required). Dr. Richard Raymond made a statement about testing poultry parts for pathogens that is stunning in its simplicity. Politically speaking, though, it’s potentially a 10.0 on the Richter scale.  He wrote, “Deputy Mande wants something that will help ‘government and industry…be held accountable by the public’ and he wants it measured. Great, I say measure what we eat–poultry parts–just like the beef industry must test and measure ground beef, not carcasses. Get poultry testing to the end product and closer to the consumer.  Let’s recognize consumers’ buying habits of the 21st century and ‘measure’ what they buy and eat.”

He was writing about the pair of FSIS/FDA/CDC joint public meetings to hear stakeholders’ thoughts on how to measure progress in food safety.  One was held July 21 in Chicago and the other will be held October 20, 2010, in Portland, Oregon.  His final question: Do I need to go to Portland, or does this count as my presentation?

Dr. Raymond, I think you need to book a flight to the West coast.

Right now, the meat and poultry industry conducts a vigorous program of production site testing.  Processing chicken? Test for Salmonella right then and there–look at the whole bird but don’t worry about its pieces and parts right now.  Grinding beef?  Take a sample immediately and ask a lab for a report on the possible presence of E. coli O157:H7.  The hoped for results of course, are that all the products leaving the point of production are pathogen-free.  It helps get companies like Tyson and JBS off the legal tenterhooks of lawyers like Bill Marler and lets their top management sleep a little better at night.

But Raymond is suggesting that we take a major, way overdue long step and ‘measure what they (the public) buy and eat.’

We don’t do that very well.  Never have.  Probably never will.

The public rarely buys and eats the direct production of a Tyson or a JBS plant.  They buy what Kroger and Wal-Mart puts in the cold case.  Sure, they’ll purchase the occasional tube of ground beef placed straight into the case by a supermarket clerk but the larger purchases are the one- and two-pound re-ground and repackaged product produced in the back room.  And how often do you see a few chicken breasts or a half-dozen legs still in an unopened Tyson package?

If Dr. Raymond wants to accurately measure what the public buys and eats, what he’s really asking is supermarkets be held to the same rigorous standards as Tyson.  It’s something that industry has stoutly resisted for reasons that are short-sighted.  It keeps the legal responsibility out of their pocketbook and firmly in the hands of Tyson, JBS, Cargill, etc.  It does nothing to improve food safety in America.  

Sure it’s an added expense for retailers and it would mean adding qualified personnel at thousands of points of production.  But let’s be honest here.  If we’re all really that interested in presenting a pathogen-free-as-humanly-possible product to the consuming public, checking for pathogens at the point where the product is actually transferred to the consuming public only makes good sense.

But with apologies to Ronald Reagan, “there I go again.”  I’m still trying to link the phrase ‘good sense’ with American politics.

Want a bone-chilling food safety comment?  I asked Dr. Raymond for some final thoughts on the future of testing poultry parts.  “FSIS won’t test parts because the results would show at least 25 percent contamination with no way to reduce that statistic,” he said.  “But they really need to do it to see if dropping the rates on carcasses (a Bush Initiative) has any impact whatsoever and so they and industry can be held accountable with real and pertinent numbers.”

Serious money.

To underscore the importance of the pursuit, in the past 17 years, there have been countless special sessions at dozens of meat industry events, and seminars devoted entirely to E. coli O157:H7.  The North American Meat Processors Association has hosted a spring mini-conference and a high-intensity 2 day fall conference to the subject for the past two years.  Both events, eagerly co-sponsored by the industry’s major trade associations and publications who understand the seriousness of the subject, are sold out well in advance.

But we’re talking about just O157:H7 here, a bug that’s been extensively researched and heavily publicized.  It’s a topic that’s just as hot in the general press as it is among the packers and processors of North America.  What’s not so well researched are six less common E. coli strains that can cause serious illnesses–two dozen cases in four states this spring caused by bagged romaine lettuce.

An unappetizing truth is hundreds of strains of E. coli live in the intestines of people as well as cattle and other animals.  Forgetting the “Yuck!” factor for a moment, even if they get into the food supply, only a very few cause illness.  Six strains have been found that produce a toxin similar to O157:H7, probably accounting for the majority of the 30,000+ non-O157 E. coli cases reported annually.

Although the meat industry has never experienced an acknowledged outbreak of disease caused by one of those six strains, Bill Marler, head of the Seattle law firm that specializes in pursuing cases of food borne illnesses, launched a pre-emptive strike and petitioned the USDA to list them as adulterants.  He’s even spent about half a million dollars of his own money to test for them in samples of meat found at retail establishments.  

Responding to his petition, the meat industry says ‘not so fast’ and they’ve got a herd of influential friends in their corner.

Leading the pack is Dr. Patricia Griffin, head of the CDC’s foodborne illness epidemiology section, who understands their argument.  Talking about the various E. coli strains, she said, “The problem is it’s a little slippery to say which ones cause human illness. We don’t have it defined yet.  We know those six, and we know a few others, but the others are still in a gray zone.”

Her point is well taken.  There is not enough known about which are the potentially deadly strains and testing protocols for them are shaky at best.  It’s important to know what you’re looking for and how to find it.  Otherwise, it’s an unnecessary waste of valuable resources that need to be aimed at the known bad guys.

Even Mansour Samadpour, President of IEH Laboratories, the facility Marler hired to look for the six suspect strains, agrees with Griffin.  He thinks the USDA needs to set standards for testing, first.

A USDA standard might still be a long way off.  Dr. David Goldman, assistant administrator for the Office of Public Health Science for FSIS, claims they’ve been working for three years on a screening test but all they have to show for their labor is something that’s reliable on only four of the six suspect strains. The agency is reluctant to ban a broader range of E. coli strains until they’ve developed a reliable and rapid test.  A ban issued sooner would be labeled premature and create a huge backlash in a meat industry suddenly charged with identifying and eliminating something for which there would be no reliable tool to do the job.

“We are hopeful that in the next six months or so we would have a screen that would reliably find all six,” said Goldman. The agency expects to work on that project, though, until the end of 2011 and then study the beef supply to determine how often those strains occur in meat products.

“I don’t want to give the impression that we’re going to wait months and months for these tests, and months and months to see what’s in the beef supply. In terms of policy options, it’s not like we have to do one and then the other,” said Goldman.

Jim Hodges, executive vice president of the American Meat Institute (AMI), said banning six more E. coli strains won’t solve anything. “The food safety strategies in place in plants today are far more effective in enhancing food safety than outlawing a pathogen that nature presents us.”  

AMI Senior Vice President of Regulatory Affairs and General Counsel Mark Dopp, agreed with Hodges. “We are concerned that food safety resources in the private sector and the public sector are not infinite.  It’s important to invest in technologies that will provide meaningful food safety benefits.  We do not believe that declaring non-O157 STECS to be adulterants will enhance the food safety system, and we think that application of such a policy could consume resources that could be better spent elsewhere to achieve meaningful food safety progress.”

Although outlawing a bug simply because it exists does no good, Hodges didn’t respond to my question about testing for those six if a reliable test were available.  Simply put, if it’s proven to be a health problem, the meat industry must seize the initiative.  It has to face a doubtful public and influential politicians like U.S. Sen. Kirsten Gillibrand (D-NY) who must be satisfied that food processors are not dragging their heels.

Gillibrand sniffs at Hodges’ comments, almost like she’s just caught a whiff of bad meat.  She’s made food safety one of the cornerstones of her senate seat, going off on some bizarre tangents and scoring the occasional good point. One of those good points–her statement that the Centers for Disease Control and Prevention estimated those six strains cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year, making them a health hazard that must be faced.

Defending her bill that would tag those strains as adulterants and must be tracked, she said, “How many people have to get sick before we take action? In America, in 2010, it is unconscionable that food is still going straight to our kitchens, school cafeterias and restaurants without being properly tested to ensure its safety.”

“It’s spreading too many diseases and costing too many lives. The laws that are meant to keep us safe from hazardous foods are in critical need of updating. We need to pass this legislation to keep our families safe,” she said. 

That might be good news but the size of the settlement will never be known.  Was it a sizable chunk out of Cargill’s massive bank account or just nuisance money that will cause them little if any pain?

Indeed, it is a significant number, whatever it might be.  Cargill said the terms of the settlement will provide for Smith’s care throughout her life, a 23 year old dance instructor left paralyzed, with cognitive problems and kidney damage.  With the high cost of health care under normal circumstances plus many more years of life for the young woman, the dollars will mount quickly.

In an Associated Press interview, Bill Marler, her attorney and publisher of Food Safety News, said, “Stephanie’s tragedy has taken on a life of its own, and hopefully it will continue to focus people on why food safety is so important.”

Cargill acknowledged responsibility when it first learned of her injuries but declined to accept financial responsibility.  The company has been providing financial help to her and her family and said it “deeply regrets” her injuries while claiming it has invested more than $1 billion in meat science research and new food safety technologies.

The company does have an interesting track record in chasing the elusive food safety goal.  Here is how the company web site explains it:

“Food safety involves continuous improvement and Cargill innovations have helped food safety.

“Through significant investments in science and innovation, Cargill is working to eliminate E. coli and other naturally occurring pathogens that can lead to food-borne illnesses. Many cattle carry E. coli 0157:H7, which does not affect animal health. In the United States, Cargill has joined Epitopix and the National Cattlemen’s Beef Association on a cattle vaccine project, which is aimed at reducing E. coli in cattle before they reach Cargill processing plants. Cargill is working with about a dozen feedlots near our packing plant in Ft. Morgan, Colorado as part of a study in which approximately 100,000 cattle will be vaccinated twice at the feedlots and tested for E. coli O157:H7 at several points at the plant. The data will then be compared on a day-by-day basis with cattle that were not vaccinated.

“We co-developed steam pasteurization to reduce E. coli in the meat industry in the 1990s. We shared this innovation with the industry, rather than keep it secret for our own competitive advantage. More recently, we adopted lactic acid washes, steam vacuuming and UV scans in our meat facilities. We also introduced a hide-on carcass wash.”

The New York Times story traced the beef trimmings that went into her hamburger to four different plants in the U.S. and Uruguay.  Beef trimmings are vulnerable to contamination but large companies including Cargill do not normally test them prior to grinding.  Neither do they customarily test product sold to smaller plants.  Small plants that grind are held to much stricter policies and most now try to protect their business with a rigorous testing regimen.  Testing incoming product, though, was a step that large processors long refused to allow small plants to do under the threat of being blackballed.

In effect, the big guys were saying, “Trust our product, but don’t you dare verify.”  

Solving the Problem

The free ride given large plants is still a black hole that hasn’t been fully addressed since John Munsell was running a small grinding operation in Montana in 2002, a generation ago in food safety years.  His business was hit with repeated and ultimately fatal blows delivered by FSIS when E. coli was discovered on his ground beef product.  He urged inspectors to go after the source–he bought his beef from ConAgra, one of the largest meat packers in North America–but FSIS removed inspectors from his plant, effectively shutting him down.

In a recent interview conducted 8 years after his ordeal, Munsell made these points:

“Think about it: if the agency were to successfully trace back to the source slaughterhouse of origin of enteric bacteria like E. coli 0157:H7 and Salmonella, numerous embarrassing facts would be revealed.

“1. The behemoth slaughter plants continue to ship unsafe meat into commerce.

“2. FSIS is asleep at the wheel at the large slaughter plants, by intentional agency design, providing a “comfortable” agency non-presence.

“3. HACCP has been an unmitigated disaster, with a foundation in political science and science fiction, not pure science.

“The only way FSIS will conduct timely trace backs to the source slaughterhouses will be via legislative mandates, not by willing agency decisions.”

Standing on the other side of the argument, Scott Goltry, the American Meat Institute’s Vice President of Food Safety and Inspection Services, thinks the procedures now in place are perfectly adequate to deliver a safe product to the public.  Speaking for the trade association, he has encouraged FSIS to support the control of product pending lab analysis, better known as test and hold. In other words, check a sample in and don’t ship the batch out until the sample is ‘lab proven’ to be safe.

There is a big hole in their position on food safety, though.  AMI has recommended that the USDA review ground beef production practices and sample ground beef products that are routinely produced by the processing facility. A processor grinding a primal or producing a coarse ground product not routinely used to produce ground beef doesn’t have to comply.  The catch is the phrase “routinely used.”  

Bernard Shire, writing for Meat&Poultry magazine, said “…it’s no secret that the people who grind trim into ground beef have no real effective interventions at that stage of the process.”

Shire pointed out that “large numbers of ground beef producers have stopped making the product and switched to other types of beef processing and manufacturing, including making cooked products.  Why?  For many of them, being able to sleep at night beats lying in bed awake, wondering when their first or next E. coli positive test will happen.”

He’s echoing Mike Mina, an FSIS official during the infamous Hudson Beef recalls in 1997 who said in a presentation to a room full of grinders at a National Meat Association Conference shortly afterwards, “There are two types of businesses; those that have had a recall and those that will have a recall.”

And in the 13 years following that massive recall, things haven’t changed.  Mina’s comment is still uncomfortably true.

The modern food safety process can be likened to a very fine meshed sieve designed to catch the vast majority of contaminated meat, statistically speaking.  “Routinely used” creates an unnecessarily large hole in that sieve.  

The Bottom Line

The cost of food safety to the industry can easily be measured in the billions of dollars and that just covers research and development into the science behind it.  The cost of in-court and out-of-court settlements to satisfy foodborne illness claims will never be known.  Too many people in the industry still seem to interpret the price paid for foodborne illne
sses as merely the cost of doing business, overlooking the larger and unrecordable cost of human misery.  Just ask Stephanie Smith.

Campylobacter, Listeria, Salmonella, Shiga toxin-producing E. coli (STEC) O157, Shigella, and Yersinia infections have declined overall since 1996.  But the incidence of infections caused by Salmonella, Listeria, and Campylobacter has essentially been unchanged since 2004, causing some concern.  Why the steady advances in the science behind defeating these infections haven’t moved the dial is a question that needs an answer as soon as possible.

Confirmed cases of E. coli O157 have finally reached a government-stated goal of less than 1 of every 100,000 people, according to the CDC report.  The agency’s Foodborne Diseases Active Surveillance Network (FoodNet) identified 459 cases in the 10 states it audits.  Translated to nation-wide numbers, those data suggest over 70,000 people are hospitalized every year and approximately 60 die.  Continuing, chronic health problems suffered by survivors are an unknown factor, contested in court too often by the legal community.  The most notorious is the tragedy that struck Stephanie Smith in 2007.

Her story earned Michael Moss and other New York Times staff members a Pulitzer Prize for explanatory journalism. Their report on the effect a contaminated hamburger had on the life of a young dancer turned a harsh light on defects in federal regulations and might have been the catalyst that led to recent changes in government oversight.

Writing about the prize-winning story, the Associated Press said, “Moss used confidential corporate and government records to tell the story of a single hamburger patty that infected 22-year-old Stephanie Smith with E. coli in 2007 and left her paralyzed.”

The CDC report, which delighted meat industry trade associations, was questioned by two of the food safety system’s most vocal critics.  “The findings of this report show that although there has been some progress, significant work remains to improve our food safety system,” said Rep. Rosa DeLauro (D-CT). “We have seen the E. coli incidence go down in the past only to rise the next year.  While there was a decrease in E. coli we saw increases in other critical foodborne illnesses like campylobacteriosis and vibriosis. These trends clearly show the need for an improved food safety system.”

Food safety lawyer Bill Marler, always ready to look on the flip side of things for a darker story, blogged, “Perhaps we simply stopped counting the real number of E. coli O157:H7 cases?”

His blog pointed out that “the number of state health department epidemiologists, and the tasks they can perform, have decreased since 2006, according to a study published by the CDC on Dec. 18, 2009.  So, less funding, fewer epidemiologists means you count fewer E. coli O157:H7 cases?  How convenient–the fewer you count, the better you look.”

“So, a 25 [percent] decrease in E. coli O157:H7 illnesses at the same time state health department epidemiologists are decreasing? Hmm, sounds like ‘fuzzy math’ to me.”

Fuzzy math or not, DeLauro’s call to improve the food safety system might become a reality soon.  FSIS is preparing to implement new, more aggressive traceback procedures when meat samples at grinding plants test positive for E. coli O157:H7.

Dr. Daniel Engeljohn of FSIS said the real issue is the degree to which the agency traces the source of E. coli when samples test positive.

“It is a difference in how we do it with an investigation related to illness.  What we announced is a substantive change to more thoroughly investigate traceback to the slaughter supplier, more so than what we do today.”

Engeljohn’s plan will give FSIS a two-day head start, allowing immediate action when they get a preliminary or “presumptive” finding of E. coli in routine testing of ground beef.  Currently FSIS waits 48 hours for the presumptive test to be confirmed.  With the rapid consumption patterns of fresh ground beef, that 48 hour time lapse can allow most, if not all, the product to enter commerce and be consumed.

Montana Senator John Tester thinks the approach Engeljohn announced is still too weak and is introducing a bill that would require traceback to the original source–not just the facility that sold trimmings to a grinding plant.  He wants investigators to get to the slaughter facility where E. coli most likely was introduced.  Currently, a valid traceback system isn’t required by USDA.

Indeed, restrictions on the degree of traceback and packer prohibitions on testing incoming product at the grinding plant have left a huge hole in the food safety net.
 
Tester’s traceback plan should end a glaring shortfall in FSIS’s ability to combat E. coli O157:H7.  Last summer, a letter sent from Phil Derfler, Assistant Administrator for the Office of Policy and Program Development, to Ken Petersen, Assistant Administrator for the Office of Field Operations, underlined the problem.

Derfler’s letter, contents released by the North American Meat Processors Association last June, addressed the responsibilities of an establishment that receives and processes raw beef to control E. coli O157:H7 as opposed to the establishment that supplies the beef.

The letter states that if primals are to remain intact, E. coli O157:H7 is not considered a hazard that should be specifically addressed by the establishment that receives them.  However, if any of the product is to be ground the “responsibility for controlling this hazard falls largely on the receiving establishment”.  The ‘sending’ establishment has no responsibility.

In other words, a small processor doesn’t have to worry about E. coli being present on meat shipped in from his supplier unless the bacteria are present.  Only then does he have to worry about it, especially if he intends to grind.  It’s a peculiar government-granted conundrum.

The letter states that the key point is that “receiving establishments must perform on-going activities to verify that its HACCP plan is being effectively implemented and maintain documents that support that those activities and the frequency with which it performs them are appropriate to accomplish their intended purpose”.

However, the letter also states that this does not mean the supplying establishment has no responsibility for the safety of primal cuts, particularly if it knows the primals are intended for use as non-intact products. 

Derfler’s letter represented no change from FSIS’ thinking at the time. Because no new regulations were issued for controlling E. coli O157:H7, the North American Meat Processors Association said it was becoming increasingly difficult for further processing establishments to justify the decision that E. coli O157:H7 is a hazard not reasonably likely to occur on the subprimals they receive.

In fact, without stricter upstream cont
rols, E. coli contamination should be deemed a hazard likely to occur.  Maybe Engeljohn’s plan with an assist from Tester can solve the Catch 22 faced by small- to medium-sized suppliers of ground beef?

Q: Update me on the negotiations over Senator Sherrod Brown (D-OH) amendment to the traceability and recordkeeping section of the bill.  What were the details of the amendment and were all parties able to reach an agreement?

A: Senator Sherrod Brown’s office has been working on an amendment to ensure FDA full and speedy traceability in the case of a food safety emergency.  The National Sustainable Agriculture Coalition has worked with the Senator’s office to craft language that would not reduce FDA’s ability to identify the source of contaminated food but would recognize the different ways that food moves in the US food system.  For example, farmers selling at farmers markets cannot be expected to keep track of the names and addresses of all the customers they sell to directly but that does not create a problem because in the unlikely event that someone should get sick the customer knows where the product came from–the direct relationship between the producer and the consumer is the best protection and further recordkeeping would be unnecessary.  The negotiations are continuing on the amendment and we have not seen final language, but we trust issues related to direct marketing and to farm identity-preserved marketing will be dealt with appropriately.

Q. Senator John Tester (D-MT), wants to exempt food facilities with under $500,000 gross sales from preventative control plan requirements, and traceback and recordkeeping provisions.  It gained strong support within the sustainable Ag community and it’s based on the assumption that locally grown foods are inherently safer.  Do you agree?

A: The current FDA regulations in our view make little sense.  All farms that would otherwise be declared food facilities by FDA because of specific normal farming activities or on-farm value-adding processing activities are currently exempt from all requirements on all of their production if more than 50 percent of their gross sales are direct sales to consumers.  From the farmer perspective, an operation with substantial direct sales may be over 50 percent one year, and under 50 percent the next year depending on markets and other variables.  From the government perspective, there are no government statistics at FDA or USDA or anywhere else that track the amount of sales made directly to consumers.  In a word, the current regulation is impractical and perhaps also illogical.  The Tester approach is a great improvement over the current situation and in our view could be further improved to make it even more practical.  

Support for the Tester amendment does not rise or fall on whether one supports local food systems or not.  Current FDA regulations, which are assumed by S. 510, presume that local, directly purchased food is safer.  But it is impractical.  The Tester amendment creates a practical standard, but in no way ties it to either local food or to direct purchase.  So in reality it is current law, not the Tester amendment, which is based on assumptions about the safety of local food.

Q: Quoting several people in the Food Safety News story, Farmers Gain in Senate Food Safety Battle, David Acheson, former associate commissioner of foods at FDA, sees no solid evidence that unconventionally-grown food is microbiologically safer and said Tester’s proposal goes too far. “It is asking for trouble…and it is not sound public health policy,” he said.  Tony Corbo, a lobbyist for Food & Water Watch, pointed out that, based on the 2007 Agriculture Census released by the USDA last year, nearly 95 percent of domestic farms would be exempt.  To me, it seems to leave an enormous amount of the nation’s food production unregulated.  How should the issue of food safety be managed by those producers?

A: What is Food & Water Watch’s view on how many farms are exempt under current FDA regulation?  The answer is they don’t know.  Neither does FDA, or anyone else.  What they do know, but choose to obfuscate, is that 75 percent of the market value of all agricultural products are from farms with over $500,000 gross sales.  So yes, 95 percent of all domestic farms, but representing just a quarter of total product, would be exempt under Tester.  However, even that understates the case, as that is for all of agriculture, and the bill does not deal with livestock at all and it emphasizes specialty crops in particular.  

The percentage of the market value of specialty crops that would be exempt under Tester is far smaller than for agriculture as a whole.  So Food & Water Watch should stop playing fast and loose with numbers.  More importantly, the proposed Tester-crafted exemption is more practical and makes more sense than the existing FDA-crafted exemption.  Both, on the other hand, could be improved.

Q: Let’s wrap it up.  What do you think about the bill in its current form?

A: Watching the evolution of the FDA Food Safety Modernization Act has been an interesting experience.  National Sustainable Agriculture Committee members approached the process with deep misgivings but have been impressed by the genuine bipartisan commitment to crafting meaningful legislation.  However, in our view, the bill’s supporters and even its detractors do not generally say very much about the bill’s cost.  In a word, it is very high.  If many of the promises in the bill are ever to become reality, it will take a very significant boost in congressional appropriations for the FDA budget.  That being the case, it is paramount that everything that can be done will be done to focus the bill on the most pressing and important food safety concerns.  Spreading the net too wide will doom the effort to failure, waste taxpayer resources, and not help create a safer food supply.

See Part I of the discussion from yesterday on what the National Sustainable Agriculture Coalition likes about S. 510, what concerns the coalition has with the bill, and whether proposed amendments to S. 510 that have been introduced to help small, sustainable agriculture will jeopardize food safety.

Editor’s Note:  This article was written by Chuck Jolley, special to Food Safety News.

The contents of the FDA Food Safety Modernization Act represent a major new approach to food safety.  Looking at it with the customary cautious optimism characteristic of many food trade organizations is the National Sustainable Agriculture Coalition.  Few people doubt that a fresh approach to the nuts and bolts of a sane and effective program is necessary and the need to get it done is immediate.  It’s the details that can kill it.

The real test will be the FDA’s ability to execute the program, whatever the final bill might contain.  Any increase in oversight requires a corresponding increase in manpower and cash, something the Feds have too often been unwilling to supply.  It’s a problem recognized by the National Sustainable Agriculture Coalition.  I asked Ferd Hoefner, their policy director, to talk about his concerns.

In Part I, Hoefner talks about what the National Sustainable Agriculture Coalition likes about S. 510, what concerns the coalition has with the bill, and whether proposed amendments to S. 510 that have been introduced to help small, sustainable agriculture will jeopardize food safety. 

Q: A recent Food Safety News article about the food safety bill wrote about ‘important improvements’ urged by your organization (See Farmers Gain in Senate Food Safety Battle, April 15).  Let’s look closely at the FDA Food Safety Modernization Act.  What provisions can the National Sustainable Agriculture Coalition applaud and what were the points that concerned you as a spokesperson for small, sustainable organic agriculture?

A: The bill that was passed out of the Health, Education, Labor and Pensions (HELP) Committee last November included practical, common sense improvements to the Produce Standards section of the bill that simultaneously improve food safety outcomes and support a stronger family farm system.  These Committee-approved amendments include provisions to require the FDA to coordinate with USDA, EPA, and Fish and Wildlife Service to ensure that any on-farm food safety standards they develop are not in conflict with conservation and environmental standards.  It also includes strengthened language requiring science-based risk analysis before proceeding to regulations.  

The changes from Committee markup also include language directing FDA to consider farm scale and diversity issues as well as special consideration for certified organic farms and ranches and language instructing FDA and USDA to coordinate to establish food safety standards that are relevant to certified organic production.  

These provisions make sense because they recognize that conservation practices many farmers use to mitigate food safety risks by establishing vegetative buffers that can filter pathogens from streams and runoff and protect cropland from windborne pathogens.  FDA sensitivity to farm scale and diversity will also be critical.  Ensuring that new food safety regulations do not undermine existing National Organic Program food safety standards helps protect the market viability of one of the fastest growing sectors in the American agriculture.

Farmers are concerned with more than just the Produce Standards section of the bill, however.  The remaining improvements the National Sustainable Agriculture Coalition hopes to see in the final legislation include:

i) Adopting a risk-based approach to farm facility regulation that recognizes the broad spectrum of types of farm facilities and tailors requirements to the degree of risk that the operations could introduce into the food system.

ii) Directing FDA to reduce the amount and type of regulation and paperwork for farm facilities and for farms subject to produce standards so that food safety goals are met without creating such a complex system that it would be financially unsupportable except by very large or non-diverse farms.

iii) Ensuring that traceback requirements are practicable for farmers, including recognizing that direct marketers and identity-preserved products have traceability inherent in the market relationship and so should be exempted from further record keeping and that farmers should just be required to maintain records on the first point of sale beyond that farm gate.

iv) Including a new authority for a USDA-delivered competitive grants program for food safety training for farmers, small processors and wholesalers to help translate rules and guidance into the real world of farming and local and regional food systems. 

Q: Proponents of a stronger food safety bill are delighted that both the House and Senate version of the bill give the FDA ‘mandatory recall authority, require more frequent inspections, and ask food facilities to implement food safety plans.’  You want a lessening of the bill’s requirements for small producers.  First, define ‘small producer’ and then talk about the reasons behind your position.

A: First, we support mandatory recall authority.  

Second, we want FDA to do a rulemaking, open to public comment and based on a scientific risk analysis, to determine which farming activities and on-farm processing activities are high risk and therefore truly require that farmers develop expensive HACCP-type plans, regular on-farm FDA inspections, and full-scale traceback requirements beyond basic recordkeeping of farmgate sales.  The bill reported by the Senate Committee, and the House-passed bill, did not require such a rulemaking.  Many farmers will be surprised that things they may well consider normal farming activities that carry little or no food safety risk will make them subject to major new regulatory requirements with substantial new costs involved.  

The Senate sponsors of the bill have now agreed to incorporate a proposal sponsored by Senator Sanders of Vermont to require FDA to do such a risk analysis and publish a rule for public comment, with direct authority to exempt or modify new regulatory requirements for low risk on-farm activities.  This is an important, common sense improvement to the bill–it reduces unnecessary regulatory burdens on farmers while focusing precious FDA human and financial resources on high risk activities.  Hence, it will help produce better real world food safety outcomes.

Third, we did not ask for this provision to be limited to farms that qualify as small businesses, nor did Senator Sanders to our knowledge.  That restriction came from FDA and the staff of the bill’s sponsors.  It was agreed to in the process of negotiation.

Q: Improvements in food safety, first and foremost, is the goal of the bill.  According to the Food Safety News article, an amendment sponsored by Senator Michael Bennet (D-CO) is “intended to reduce paperwork and excess regulation and FDA will be instructed to provide flexibility for small processors including on-farm processing, minimize the burden of compliance with regulations, and minimize the number of different standards that apply to separate foods.

“FDA will also be prohibited from requiring farms and other food facilities to hire consultants to write food safety plans or to identify, implement, certify, or audit those plans.”  While it certainly gives the little guy a significant break financially, doesn’t it also unnecessarily expose the public to health risks?

A: Like the Sanders amendment, the Bennet amendment is an important, common sense provision that improves the bill.  Without the new Bennet language, the bill would require FDA to do separate food safety regulations on each crop even if a substantial amount of the rule would be common across a
ll or most crops.  It would have also required separate rules even where a single rule for a particular category of crops makes more sense.  

In our view, it is very important that the bill, as amended by Senator Bennet, now directs FDA to reduce unnecessary paperwork burden on farmers and small processors.  It is also very important that the legislation is clear that FDA as a general rule will not require food facilities, including farms that are declared food facilities, from hiring expensive consultants or auditors.  FDA has always said that was never its intent, but now that statement of intent is actually in the bill, where it appropriately belongs.

Editor’s Note:  This article was written by Chuck Jolley, special to Food Safety News. 

See Food Safety News tomorrow for Part II of the discussion about the FDA Food Safety Modernization Act.